Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1032-2014·Announced 2014-02-26

Zimmer Recalls CPT 12/14 COCR Medical Devices Due to Packaging Validation Issues

Zimmer is recalling CPT 12/14 COCR devices 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, but the source text indicates 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 approximately 7,044,680 units of CPT 12/14 COCR medical devices in various sizes. The recall affects devices 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 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 lots from this specific facility to ensure safety.

The affected products were distributed worldwide, including in the United States and numerous international markets such as Canada, the United Kingdom, Germany, and Japan. Healthcare providers and patients should check their inventory and device records to identify if they possess any of the affected lots listed in the recall notice.

The recalled product

Product: CPT 12/14 COCR (various sizes)
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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