Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1014-2014·Announced 2014-02-26

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

Zimmer is recalling 7,044,680 one-piece lag screws because packaging operations at its Puerto Rico facility were not properly validated, despite passing 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: The recall is classified as FDA Class II. The source text explicitly states that the products met acceptance criteria for sterile barrier integrity and no illnesses or injuries are reported, fitting the rubric for a voluntary precautionary recall.

Plain-English summary

Zimmer, Inc. is recalling 7,044,680 units of One-Piece Lag Screws 11mm (item codes starting with 00225900). The recall covers all manufacturing lots that have not expired and were 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 packaging operations in Building 1 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) for both inner and outer trays, Zimmer decided to recall the affected lots as a precaution.

The affected products were distributed nationwide in the United States and in numerous countries worldwide, including Belgium, Canada, China, France, Germany, India, Italy, Japan, and the United Kingdom. Consumers and healthcare providers should check their inventory for the specific item codes listed in the recall notice and contact Zimmer for instructions on how to return or dispose of the affected devices.

The recalled product

Product: ONE-PIECE LAG SCREW 11MM. Item codes starting with 00225900.
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implants
Hazard: packaging-validation
sterile-barrier-integrity
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 →

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