Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1001-2014·Announced 2014-02-26

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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.
Category: Medical Device — Orthopedic Implants
Hazard: sterility-compromise
packaging-defect
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.

See all 44 products in this recall →

Same manufacturer · Zimmer, Inc.

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