Zimmer Recalls Sterile Orthopedic Screws and Nails Due to Packaging Validation Issues
Zimmer is recalling specific sterile orthopedic screws and nails because packaging operations at its Puerto Rico facility were not properly validated, despite passing 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, but the source text explicitly states that the products met acceptance criteria for sterile barrier integrity and no illnesses or injuries are reported, fitting the criteria for a voluntary precautionary recall.
Plain-English summary
Zimmer, Inc. is recalling specific lots of RECON SCREW LG 5.5MM DIA and M/DN FEM IM NAIL 8MM DIA to 16 MM DIA. The recall involves 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.
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 with 99% reliability and a 90% confidence interval, Zimmer decided to recall all non-expired manufacturing lots from this specific facility and operation.
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 item codes and lot numbers listed in the official recall notice. If the products are found, they should be removed from use and returned to the supplier or manufacturer according to the recall instructions.
The recalled product
- Product
- RECON SCREW LG 5.5MM DIA and M/DN FEM IM NAIL 8MM DIA to 16 MM DIA. Item codes starting with 0022520, 0022521, 002522, 0022523, 0022524 and 0022525.
- 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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