Zimmer Recalls Orthopedic Implants Due to Packaging Validation Deficiencies
Zimmer is recalling specific orthopedic implants because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.
What this means for you
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 seal integrity testing, but the recall was initiated due to a lack of proper validation documentation rather than a confirmed defect or reported injury.
Plain-English summary
Zimmer, Inc. is recalling specific orthopedic implant components, including distal medial femoral cones, distal posterior/lateral components, distal small volar radius components, proximal dorsal ulna plates, and proximal medial tibial 4 components. The recall affects 7,044,680 total units that were sterile packaged in the Building 1 packaging operations at the Zimmer Manufacturing B.V. facility in Ponce, Puerto Rico.
The recall was initiated after Zimmer reviewed historic packaging validations and determined that packaging operations in Building 1 were not properly validated. Although Zimmer conducted seal integrity testing and the packaging tray configurations met the acceptance criteria for sterile barrier integrity, the company decided to recall all non-expired manufacturing lots from this specific facility and operation.
The affected products were distributed nationwide in the United States and in numerous countries worldwide, including Belgium, Canada, China, France, Germany, India, Italy, Japan, and the United Kingdom. Consumers and healthcare providers should check their inventory against the specific catalog codes listed in the official recall notice to determine if they possess affected units.
The recalled product
- Product
- DISTAL MEDIAL FEMORAL CON, DISTAL POSTERIOR/LATERAL, DISTAL SMALL VOLAR RADIUS, PROXIMAL DORSAL ULNA PLT, and PROXIMAL MEDIAL TIBIAL 4.
- 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 recalled for breakage
FDA (Devices) · 2026-07-01
- ModerateZimmer Shoulder System Reamer Guide 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 Shoulder Reamer Guide System Recalled for Plastic Breakage
FDA (Devices) · 2026-07-01
- HighZimmer Off-Axis Alliance Glenoid Reamer Guide Plastic Breakage Recall
FDA (Devices) · 2026-07-01
Same hazard · packaging validation
See all →- ModerateZimmer Recalls One-Piece Lag Screws Due to Packaging Validation Issues
FDA (Devices) · 2014-02-26
- ModerateZimmer Recalls Hip Prostheses Due to Unvalidated Packaging Operations
FDA (Devices) · 2014-02-26
- ModerateZimmer Recalls Free-Lock Orthopedic Devices Due to Packaging Validation Issues
FDA (Devices) · 2014-02-26
- ModerateZimmer Recalls Versys Heritage Femoral Stems Due to Packaging Validation Issues
FDA (Devices) · 2014-02-26
- ModerateZimmer Recalls CPT 12/14 COCR Medical Devices Due to Packaging Validation Issues
FDA (Devices) · 2014-02-26