Zimmer Biomet Recalls Hip Prostheses Due to Black Residue in Packaging
Zimmer Biomet is recalling specific M/L Taper Hip Prostheses manufactured before October 2015 because black residue was found in the packaging bags.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where the hazard (debris causing wear) could lead to injury or surgical intervention, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Zimmer Biomet, Inc. is recalling 294 units of the Zimmer M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Standard Offset (catalog number 00-7711-004-10). The recall covers devices manufactured prior to October 2015. The affected products were distributed solely to Japan.
The recall was initiated due to the potential for black residue to be observed within the polyethylene bag containing the implant. The company states that this residue is a combination of the titanium plasma spray used to create the porous surface of the implant and the polyethylene bag itself. Zimmer Biomet asserts that the residue is biocompatible.
The identified risks include the potential delay of surgery while locating a replacement device and the possibility of surgical intervention due to wear caused by debris. Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the replacement of these devices.
The recalled product
- Product
- Zimmer¿ M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Standard Offset; 00-7711-004-10
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 294
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 15 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 15 products in this recall →Related recalls
Same manufacturer · Zimmer Biomet, Inc.
See all →- HighZimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
- ModerateZimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
- HighZimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11
Same hazard · debris
See all →- HighFDA Recalls Grappler Suture Anchors Due to Potential Breakage Risk
FDA (Devices) · 2022-09-28
- ModerateStryker Restoration Anatomic Shell Recalled for Packaging Defect
FDA (Devices) · 2020-05-27
- HighDePuy Orthopaedics Recalls CORAIL AMT COXA VARA Neck Segments
FDA (Devices) · 2019-04-17
- HighDePuy CORAIL AMT High Offset Neck Segment Recall for Potential Debris
FDA (Devices) · 2019-04-17
- HighDePuy CORAIL Neck Trials Recalled for Potential Debris Behind O-rings
FDA (Devices) · 2019-04-17