Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC)
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Implants & Prosthetics
🏥 Medical Devices • 4,589 recalls
Class I - Dangerous
The affected products are missing polar boss threads.
Class I - Dangerous
Incorrect dimension on four liners was detected
Class I - Dangerous
Packaging of a device was compromised
An investigation identified that the product was incorrectly manufactured as a left humeral trial but is etched as a right humeral trial.
MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during procedures to clear away bone and cartilage within the desired implant area.
Orthohelix Surgical Designs
Class I - Dangerous
Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer
The Hulka Clip is a sterile packaged medical device that carries a two year expiration date. It is packaged two clips per procedural tray. Theses procedural trays are then sealed in a Tyvek/Mylar pouch and packaged in a cardboard shipping carton with ten pouches in each shipping carton.
Richard Wolf Medical Instruments
Class I - Dangerous
Richard Wolf Medical Instrument Corporation is recalling Hulka Clip Tubal Occluding Device lot 51000232. The devices are being recalled as a part of an investigation into a biocompatibility test discrepancy where the recalled lot (lot 51000232) passed final release testing, but the subsequent lot failed biocompatibility testing on a component that was also used to manufacture lot 51000232.
Class I - Dangerous
Investigation determined that units supplied were missing the 4x21 degree helix angle.
Class I - Dangerous
The Persona 48mm X 2.5mm Female Screw is being recalled due to potential use of the screw in cortical bone, and corresponding stripping of the 2.5mm Persona Hex Driver.
ArjoHuntleigh received reports where the Tenor Lift without Scale (spreader bar) bolt broke during use. There is a remote risk concerning the breakage of the spreader bar bolt connection, part # TEN.018. During use, the bolt is subjected to mechanical forces, which may lead to breakage.
Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing.
Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing.
Weld fractures on the Sleeve Installation Tool for ACL reconstruction system.
Zimmer received a trend of complaints indicating corrosion of product.
Zimmer received a trend of complaints indicating corrosion of product.
Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument are aware of the enhanced surgical techniques.
Zimmer received a trend of complaints indicating corrosion of product.
Product mix occurred prior to final package and labeling process.
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.