Possibility that the inner pouch may be compromised. The product is packaged in two pouches - a sterile inner pouch within an external pouch. NexPosure Retractors contained in a breached inner pouch have an increased risk of contamination (i.e.; loss of product sterility) if proper aseptic technique is not followed when transferring the inner package into the sterile field. Patient infection may o
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Implants & Prosthetics
ðĨ Medical Devices âĒ 4,589 recalls
LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.
LeMaitre Vascular
Class I - Dangerous
Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.
PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.
Keystone Dental
Class I - Dangerous
Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled
Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER File K2401. For use in knee prosthesis implantation. NON-STERILE
Stryker Howmedica Osteonics
Class I - Dangerous
The standard Triathlon Femoral Stylus does not fit into the Specialty Sizers and the "R" and "L" markings on the Right Sizer are reversed.
Class I - Dangerous
It was discovered that one of the VA-LCP Dorsal Distal Radius Plates was incorrectly etched as Part Number 02.115.431 (110 degree) instead of the correct Part Number 02.115.231 (90 degree).
Potential for the IM rod to break, leaving fragments in the patient. Surgical Techniques guidance has been updated until design changes can be made to reduce likelihood of potential failure.
Class I - Dangerous
A dimensional mismatch was identified which can potentially allow for interference between devices.
Class I - Dangerous
The tabs on the reamer extension device have broken. DePuy is notifying surgeons of the issue to increase the awareness and to ask surgeons and users to look for tabs before and after surgery to reduce any potential that the tabs are left in the patient. Once the root cause is determined and a design change is implemented, DePuy will conduct a formal swap-out of the affected devices.
Class I - Dangerous
Mislabeled: Genesis Straight Esthetic 4.0mm Contour ,1mm cuff labeled as Genesis Straight Esthetic 5.0 mm, 3mm cuff abutment
Class I - Dangerous
Mislabeled: Genesis Straight Esthetic 5.0mm Contour ,3mm cuff labeled as Genesis Straight Esthetic 4.0 mm, 1 mm cuff abutment,
Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100
Stryker Howmedica Osteonics
Class I - Dangerous
Reports of handle fracture and subsequent disassociation of cam assembly subcomponents during use.
Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft, for use with supplemental fixation.
Spine Smith Partners
Class I - Dangerous
Implants were incorrectly laser marked as 23mm instead of 28mm.
Class I - Dangerous
Isoline defibrillation leads distributed may have internal insulation breach.
Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.
Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports.
Churchill Medical Systems
Class I - Dangerous
The label on the device states that the item number is CLGY-2210 when the item number on the device label should read CLGY-2010. This is a 20Ga Huber needle set; however, the product label states the pouch contains a 22Ga set.
Medacta USA is recalling Versafitcup Impacting Ring because the impaction ring may not fit properly in the implant shell in all cases. This could result in surgical delay potentially increasing possible complications under anesthesia, having to ream up to a larger shell size leaving less bone than planned and repositiong/removal of the shell after initial impaction.
Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.
Advanced Neuromodulation Systems
Class I - Dangerous
Unintended Fluid ingress into the device header has been shown.
A report of an event was received indicating that upon opening a box containing 10 sterile cannula by a nurse, the pouch package of 5 of the 10 individually packaged cannula had not been sealed along one edge. Thus the pouch was open and the device could fall out of the pouch and on to the floor when retrieved from the shelf box. The cannulas were not used on any patients, as the unsealed packages
Class I - Dangerous
DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients.
Class I - Dangerous
DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients.