Zimmer Recalls Self-Tapping Cortical Screws Due to Packaging Validation Issues
Zimmer is recalling 7 million self-tapping cortical screws because packaging operations at a 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 seal integrity testing met acceptance criteria and no illnesses or injuries are reported. This fits the rubric for a voluntary precautionary recall with low-risk contamination concerns.
Plain-English summary
Zimmer, Inc. is recalling approximately 7,044,680 units of self-tapping cortical screws in various lengths (3.5 x 10 mm to 3.5 x 75 mm). The recall affects products 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 at the specified facility 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 all non-expired manufacturing lots from this specific packaging line as a precaution.
The affected products were distributed worldwide, including the United States and numerous international markets such as Canada, the United Kingdom, Germany, and Japan. Healthcare providers and facilities that have received these specific lots should stop using them and contact Zimmer for instructions on return or replacement.
The recalled product
- Product
- 3.5 X 10 CORT SCREW SELFT 3.5 X 12 CORT SCREW SELFT 3.5 X 14 CORT SCREW SELFT 3.5 X 16 CORT SCREW SELFT 3.5 X 18 CORT SCREW SELFT 3.5 X 20 CORT SCREW SELFT 3.5 X 22 CORT SCREW SELFT 3.5 X 24 CORT SCREW SELFT 3.5 X 26 CORT SCREW SELFT 3.5 X 28 CORT SCREW SELFT 3.5 X 30 C
- 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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