Zimmer Recalls Bone Screws Due to Packaging Validation Deficiencies
Zimmer is recalling specific bone screws because packaging operations at its 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: The recall is classified as FDA Class II. The hazard is theoretical because the products passed subsequent seal integrity testing, and no illnesses or injuries are reported in the source text.
Plain-English summary
Zimmer, Inc. is recalling specific lots of HERBERT MINI BONE SCREW 2 and HERBERT/WHIPPLE C ANN BONE items. The recall affects 7,044,680 units that were sterile packaged in the Building 1 packaging operations at the Zimmer Manufacturing B.V. facility in Ponce, Puerto Rico. These products were distributed nationwide in the United States and in numerous international markets, including Canada, the United Kingdom, and various countries in Europe, Asia, and the Pacific.
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 indicated that the packaging trays met acceptance criteria for sterile barrier integrity, Zimmer decided to recall all non-expired manufacturing lots from this specific facility to ensure patient safety.
Healthcare providers and patients should check their inventory and records for the specific product codes listed in the official recall notice. If you have used or are considering using these specific lots, contact your healthcare provider or Zimmer for further instructions on replacement or disposal.
The recalled product
- Product
- HERBERT MINI BONE SCREW 2 and HERBERT/WHIPPLE C ANN BONE. Items starting with 0011500 and 0011520.
- 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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