Zimmer Recalls Versys Femoral Stems Due to Packaging Validation Issues
Zimmer is recalling Versys femoral stems because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a voluntary precautionary recall (FDA Class II) where the product passed subsequent seal integrity testing and no injuries or illnesses have been reported, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer, Inc. is recalling specific lots of Versys femoral stems and related components. The recall involves 7,044,680 units distributed worldwide, including the United States and numerous international markets.
The recall was initiated after Zimmer reviewed historic packaging validations at its Zimmer Manufacturing B.V. facility in Ponce, Puerto Rico. The review determined that packaging operations in Building 1 were not properly validated. Although subsequent seal integrity testing showed the packaging met acceptance criteria for sterile barrier integrity, Zimmer decided to recall all non-expired lots sterile packaged in that specific facility area.
Patients who have had these implants placed should contact their healthcare provider for guidance. The source text does not report any illnesses, injuries, or deaths associated with these devices.
The recalled product
- Product
- 12/14 UNIPOLAR FEMORAL HE VERSYS CEM LD/FX SZ 11X12 VERSYS CEM LD/FX SZ 12X12 VERSYS CEM LD/FX SZ 14X13 VERSYS CEM LD/FX SZ 16X14 VERSYS CEM LD/FX ST 18X15 VERSYS PRESS FIT LD/FX ST VERSYS PRESS FIT LD/FX SZ VERSYS ADVOCATE CEMENTED VERSYS ADVOCATE V-LIGN CE VERSYS…
- Manufacturer
- Zimmer, Inc.
- Affected units
- 7,044,680
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 44 recalled by Zimmer, 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 44 products in this recall →Related recalls
Same manufacturer · Zimmer, Inc.
See all →- HighZimmer Off-Axis Alliance Glenoid Reamer Guide Plastic Breakage Recall
FDA (Devices) · 2026-07-01
- HighZimmer Off-Axis Alliance Glenoid Reamer Guide recalled for breakage
FDA (Devices) · 2026-07-01
- HighZimmer Shoulder Reamer Guide System Recalled for Plastic Breakage
FDA (Devices) · 2026-07-01
- ModeratePersona Revision Trabecular Metal Femoral Distal Augment recalled for packaging defect
FDA (Devices) · 2026-07-01
- HighZimmer Off-Axis Comprehensive Shoulder System Reamer Guide Recall
FDA (Devices) · 2026-07-01
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- LowZimmer Versys Femoral Stem Recall Due to Packaging Adhesion
FDA (Devices) · 2013-11-06
- ModerateZimmer Biomet Recalls Sterile Porous Femoral Stems Due to Packaging Failures
FDA (Devices) · 2017-06-21
- ModerateZimmer Recalls Hip Stems Due to Sterile Barrier Integrity Testing
FDA (Devices) · 2013-11-20
- ModerateZimmer Versys Heritage Femoral Stem Recall Due to Sealer Calibration
FDA (Devices) · 2016-03-23
- ModerateZimmer Biomet Recalls Sterile Intramedullary Femoral Stems Due to Packaging Failures
FDA (Devices) · 2017-06-21
- ModerateZimmer Versys Cemented Femoral Stem Recall for Calibration Issues
FDA (Devices) · 2016-03-23