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.
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 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.
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