Zimmer Recalls Magna-Fx Cannulated Screws Due to Packaging Validation Issues
Zimmer is recalling Magna-Fx Cannulated Screw Fixation Systems 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 the Magna-Fx Cannulated Screw Fixation System 7.0 mm, specifically item codes starting with 0011420, 11460, and 11461. The recall involves 7,044,680 units that were distributed nationwide in the United States and in numerous countries worldwide, including Belgium, Canada, China, France, 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 that were 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 used or possess these devices, contact Zimmer, Inc. for further instructions on the recall process.
The recalled product
- Product
- Magna-Fx Cannulated Screw Fixation System 7.0 mm. Item codes starting with 0011420, 11460 and 11461.
- 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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