Zimmer Recalls HGP II Acetabular Cup Due to Packaging Validation Issues
Zimmer is recalling HGP II Acetabular Cup Bon due to unvalidated packaging operations at its Puerto Rico facility, 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 based on a validation documentation issue. The source text explicitly states that the product met acceptance criteria for sterile barrier integrity, and no illnesses or injuries are reported.
Plain-English summary
Zimmer, Inc. is recalling the HGP II Acetabular Cup Bon. The recall involves 7,044,680 units distributed worldwide, including the United States and numerous international markets. The affected products were sterile packaged in the Building 1 packaging operations at Zimmer Manufacturing B.V. in Ponce, Puerto Rico.
The recall was initiated after Zimmer reviewed historic packaging validations and determined that packaging operations at the specified facility 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 manufacturing lots from this specific operation to ensure safety.
Healthcare providers and patients should contact Zimmer for further instructions regarding the affected lots. The recall covers specific lot codes listed in the official FDA notice.
The recalled product
- Product
- HGP II ACETABULAR CUP BON
- 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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