Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1038-2014·Announced 2014-02-26

Zimmer Recalls Bone Screws Due to Unvalidated Packaging Operations

Zimmer is recalling 7,044,680 units of Herbert Bone Screws and Cannulated Bone Screws because packaging operations at a Puerto Rico facility were not properly validated.

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, 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 based on confirmed failures or reported injuries.

Plain-English summary

Zimmer, Inc. is recalling 7,044,680 units of HERBERT BONE SCREW, 3.0MM and HERBERT CANNULATED BONE SCREW products. The recall affects units that were sterile packaged in the Building 1 packaging operations at the Zimmer Manufacturing B.V. facility in Ponce, Puerto Rico. The products were distributed nationwide in the United States and in numerous international countries, including Belgium, Canada, China, Germany, India, Japan, and the United Kingdom.

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 safety.

Healthcare providers and patients should check their inventory and patient records for these specific products. If you have used or possess these items, contact Zimmer, Inc. for further instructions on how to return or dispose of the recalled products.

The recalled product

Product: HERBERT BONE SCREW, 3.0MM and HERBERT CANNULATED BONE S
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 →

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