Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6
Zimmer GmbH
85 recalls • • Categories: Implants & Prosthetics, Other Medical Devices, Infusion Pumps
Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6
Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree
Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree
Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Mislabeled Labeled Avenir M¿ller Stem size 1, the stem inside the packaging is an Avenir M¿ller Stem size 2 .
Class I - Dangerous
A potential commingle that could result in the product in the package not matching the product on the outer label.
Class I - Dangerous
A potential commingle that could result in the product in the package not matching the product on the outer label.
Class I - Dangerous
Product may contain a gap between the handle and metal chisel which can lead to failure to properly disinfect or sterilize between use.
the devices used a different raw material to produce two countersink products which has higher hardness and higher carbon content resulting in device damage.
Class I - Dangerous
Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire (K-Wire) component.
Class I - Dangerous
Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire (K-Wire) component.
Class I - Dangerous
Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire (K-Wire) component.
Class I - Dangerous
Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire (K-Wire) component.
Product mix-up. The Avenir M¿ller Stem 6 lateral uncemented might be placed in the packaging of the Avenir M¿ller Stem 4 standard uncemented and vice versa. Potential for delay in surgery, and/or potential for use of incorrect implant which may in turn lead dismetry in patient and possibly the need for revision.
In some cases it has been difficult or not possible to disassemble the adjusted Dome Centric from the AS Humeral Rasp after initial positioning of the AS Humeral Trial Head which resulted in the whole construct of the Dome Centric with the still assembled AS Humeral Rasp taken out of the humeral canal. This could cause a delay in surgery time or the surgeon could decide to close the wound without finishing the surgery, increasing the infection risk or second use of anesthesia necessary.
Class I - Dangerous
In about 5% of tested samples, the outer tray was found to be compromised. Risks: A damaged outer tray detected during surgery may cause a delay in surgery to obtain another implant. If a compromised packaging is not detected prior or during a surgery by the user, it may lead to periprosthetic infection. This may result in revision or multi-stage revision to treat the infection.
Class I - Dangerous
Complaints of difficulties to attach the Anatomical Shoulder Rasps (high resistance) or, once attached, due to difficulties to remove the handle (seizing up of the two components). This has the potential for delay in surgery.
Class I - Dangerous
Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.
Class I - Dangerous
Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.
Class I - Dangerous
Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.
Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.
Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.