Zimmer Biomet Recalls Specific Lots of Trabecular Metal Implants
Zimmer Biomet is recalling specific lots of sterile Trabecular Metal implants manufactured between April 2011 and October 2012 due to a defect in the foil pouches used for sterile integrity.
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 defect in the sterile barrier system of a medical implant, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants. The affected products were manufactured between April 2011 and October 2012.
The recall is being conducted because the foil pouches, which are part of a dual barrier system designed to provide sterile integrity, are subject to a defect. The source text does not specify the exact nature of the defect or the number of units affected.
Healthcare providers and facilities that have received these specific lots of Trabecular Metal implants should contact Zimmer Biomet for further instructions on how to handle the recalled products. The source text does not provide specific contact information or a list of affected lot numbers.
The recalled product
- Product
- POROUS PATELLA 32MM X 10MM - 00587806532 POROUS PATELLA 35MM X 10MM- 00587806535 POROUS PATELLA 38MM X 10MM - 00587806538 POROUS PATELLA 41MM X 10MM - 00587806541
- Manufacturer
- Zimmer Trabecular Metal Technology, Inc.
- Hazard
- Affected units
- 19,884
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Zimmer Trabecular Metal Technology, 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 6 products in this recall →Related recalls
Same manufacturer · Zimmer Trabecular Metal Technology, Inc.
See all →- ModerateZimmer NexGen Trabecular Metal Tibial Augment Recall for Label Mismatch
FDA (Devices) · 2019-03-20
- HighFDA Recalls NexGen Trabecular Metal Tibial Augments Due to Labeling Mismatch
FDA (Devices) · 2019-03-20
- LowZimmer TM Ardis Interbody System Recalled for Procedural Error in Literature Approval
FDA (Devices) · 2017-05-10
- HighZimmer Trabecular Metal Implants Recalled for Sterility Concerns
FDA (Devices) · 2016-06-22
- HighZimmer Trabecular Metal Implants Recalled for Sterile Integrity Concerns
FDA (Devices) · 2016-06-22
Same hazard · sterility compromise
See all →- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12