Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1012-2014·Announced 2014-02-26

Zimmer Recalls Asia One-Piece Lag Screws Due to Packaging Validation Issues

Zimmer is recalling 7,044,680 Asia One-Piece Lag Screws because packaging operations at a Puerto Rico facility were not properly validated, potentially affecting sterile barrier integrity.

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: 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, fitting the criteria for a voluntary precautionary recall.

Plain-English summary

Zimmer, Inc. is recalling 7,044,680 units of the ASIA ONE-PIECE LAG SCREW. The recall is due to a review of historic packaging validations at the Zimmer Manufacturing B.V. facility in Ponce, Puerto Rico, which determined that packaging operations in Building 1 were not properly validated.

Although subsequent seal integrity testing indicated that the packaging trays met acceptance criteria for sterile barrier integrity, Zimmer has decided to recall all non-expired manufacturing lots that were sterile packaged in the affected facility operations. The affected products were distributed nationwide in the United States and in numerous international locations, including Canada, the United Kingdom, and various countries in Europe, Asia, and the Pacific.

Healthcare providers and patients should stop using the recalled products and contact Zimmer, Inc. for further instructions or replacement. The recall number is Z-1012-2014.

The recalled product

Product: ASIA ONE-PIECE LAG SCREW
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: sterility-compromise
Affected units: 7,044,680

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

61671102 62142296

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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