Zimmer Recalls M/DN R-F IM Nails Due to Packaging Validation Issues
Zimmer is recalling M/DN R-F IM 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: This is a voluntary precautionary recall (FDA Class II) where the product passed seal integrity testing, and no illnesses or injuries are reported in the source text.
Plain-English summary
Zimmer, Inc. is recalling M/DN R-F IM Nails in diameters of 9mm, 10mm, 11mm, 12mm, 13mm, and 14mm. The affected items have codes starting with 0022400. This recall involves 7,044,680 units that were distributed nationwide in the United States and in numerous countries worldwide, including Belgium, Canada, China, Germany, India, Japan, and the United Kingdom.
The recall was initiated after Zimmer reviewed historic packaging validations at its Zimmer Manufacturing B.V. facility in Ponce, Puerto Rico. The review determined that packaging operations in Building 1 were not properly validated. Although subsequent seal integrity testing showed that the packaging trays met acceptance criteria for sterile barrier integrity, Zimmer decided to recall all non-expired lots sterile packaged in that specific facility to ensure safety.
Healthcare providers and patients should check their inventory and records for these specific item codes. If you have these products, do not use them. Contact Zimmer, Inc. for further instructions on how to return or dispose of the recalled items.
The recalled product
- Product
- M/DN R-F IM NAIL 9MM DIA , 10 MM, 11 MM, 12 MM, 13 MM and 14 MM. Item codes starting with 0022400
- 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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