Zimmer Recalls CPT Degree Taper and Femoral HD Medical Devices
Zimmer is recalling CPT Degree Taper and Femoral HD devices due to unvalidated packaging operations at a Puerto Rico facility.
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: The recall is classified as FDA Class II, but the source text indicates that seal integrity testing met acceptance criteria and no illnesses or injuries are reported, fitting the criteria for a voluntary precautionary recall.
Plain-English summary
Zimmer, Inc. is recalling CPT Degree Taper and Femoral HD medical devices in various sizes. The recall involves 7,044,680 units distributed nationwide in the United States and internationally to numerous countries including Belgium, Canada, China, Germany, Japan, and the United Kingdom.
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 that the packaging met acceptance criteria for sterile barrier integrity, Zimmer decided to recall all non-expired lots sterile packaged in that specific facility to ensure safety.
Healthcare providers and patients should check their inventory and records for these specific product codes and sizes. If you have these devices, contact Zimmer or your healthcare provider for instructions on how to proceed with the recall.
The recalled product
- Product
- CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes)
- 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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