Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1004-2014·Announced 2014-02-26

Zimmer Recalls Sterile Orthopedic Screws Due to Packaging Validation Issues

Zimmer is recalling specific sterile orthopedic screws because packaging operations at a 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: 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 approximately 7,044,680 units of sterile orthopedic lag screws. The affected products include various sizes of 12.7mm and 15.8mm diameter screws, identified by item codes starting with 001930. These devices were sterile packaged in the Building 1 packaging operations at Zimmer Manufacturing B.V. in Ponce, Puerto Rico.

The recall was initiated after Zimmer reviewed historic packaging validations and determined that the packaging operations at the specified facility were not properly validated. Although subsequent seal integrity testing showed that the packaging trays met the acceptance criteria for sterile barrier integrity (99% reliability with a 90% confidence interval), Zimmer decided to recall all non-expired manufacturing lots from this specific packaging line as a precautionary measure.

The affected products were distributed worldwide, including in the United States and numerous international markets. Healthcare providers and patients should check their inventory and patient records for these specific item codes. If you have used or possess these devices, contact Zimmer or your healthcare provider for further instructions.

The recalled product

Product: Item codes starting with 001930 LAG SCR 12.7D X 55MM SHOR up to 155 MM, LAG SCR 12.7D X 55 MM SHO up to 100MM, LAG SCR 12.7D X 55MM STAN up to 155 MM, LAG SCR 15.8D X 55MM LARG up to 155 MM
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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