The Recall Desk
ModerateFDA (Devices)·Z-1017-2014·Announced 2014-02-26

Zimmer Recalls Hip Prostheses Due to Packaging Validation Issues

Zimmer, Inc. is recalling specific hip prosthesis models because packaging operations at a Puerto Rico facility were not properly validated, raising concerns about sterile barrier integrity.

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: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The source text notes that seal integrity testing met acceptance criteria, suggesting the risk is precautionary rather than confirmed failure, aligning with a Moderate severity score.

Plain-English summary

Zimmer, Inc. is recalling specific hip prosthesis models, including the Moore Hip Pros Long Fenes, Moore Hip Pros NRW Str Fe, Moore Hip Pros Str Fenest, Thompson Hip Prosthesis (sizes 3, 4, 5, and 6), and Mod Austin Moore Fem Stem. The recall involves 7,044,680 units that 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 the packaging operations in Building 1 were not properly validated. Although subsequent seal integrity testing indicated that the packaging tray configurations met acceptance criteria for sterile barrier integrity, Zimmer decided to recall all non-expired manufacturing lots from this specific facility to ensure patient safety.

The affected products were distributed nationwide in the United States and in numerous international countries, including Belgium, Canada, China, France, Germany, India, Italy, Japan, and the United Kingdom. Patients who have had these specific hip prostheses implanted should contact their healthcare provider to discuss the recall and determine if any further action is necessary.

The recalled product

Product
MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS sizes 3, 4, 5, and 6, and Mod Austin Moore Fem Stem
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Implants
Hazard
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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