Zimmer Recalls Bipolar Liners and Multipolar Cups Due to Packaging Validation Issues
Zimmer is recalling 7,044,680 units of bipolar liners and multipolar cups because packaging operations at a Puerto Rico facility were not properly validated, despite passing subsequent 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 subsequent seal integrity testing, and no illnesses or injuries are reported in the source text.
Plain-English summary
Zimmer, Inc. is recalling 7,044,680 units of bipolar liners and multipolar cups. The affected products were sterile packaged in the Building 1 packaging operations at the Zimmer Manufacturing B.V. facility in Ponce, Puerto Rico. The recall includes all manufacturing lots that have not expired and were packaged in this specific facility.
The recall was initiated after Zimmer reviewed historic packaging validations and determined that the packaging operations in Building 1 were not properly validated. Although subsequent seal integrity testing showed that the packaging tray configurations met the acceptance criteria for sterile barrier integrity (99% reliability with a 90% confidence interval), Zimmer decided to recall the products as a precautionary measure.
The affected products were distributed worldwide, including in the United States and numerous international markets. Consumers and healthcare providers should check their inventory for the specific product codes listed in the official recall notice and contact Zimmer for further instructions on how to handle the recalled items.
The recalled product
- Product
- Bipolar liners and Multipolar cups with the following dimensions in MM (38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 53, 54, 55, 57, 58, 60, 64, 66, 68, 70, 72) and several OD
- 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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