Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1019-2014·Announced 2014-02-26

Zimmer Recalls Bipolar Liners and Multipolar Cups Due to Packaging Validation Issues

Zimmer is recalling 7,044,680 units of bipolar liners and multipolar cups because packaging operations at a Puerto Rico facility were not properly validated, despite passing subsequent 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 subsequent seal integrity testing, and no illnesses or injuries are reported in the source text.

Plain-English summary

Zimmer, Inc. is recalling 7,044,680 units of bipolar liners and multipolar cups. The affected products were sterile packaged in the Building 1 packaging operations at the Zimmer Manufacturing B.V. facility in Ponce, Puerto Rico. The recall includes all manufacturing lots that have not expired and were packaged in this specific facility.

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 tray configurations met the acceptance criteria for sterile barrier integrity (99% reliability with a 90% confidence interval), Zimmer decided to recall the products as a precautionary measure.

The affected products were distributed worldwide, including in the United States and numerous international markets. Consumers and healthcare providers should check their inventory for the specific product codes listed in the official recall notice and contact Zimmer for further instructions on how to handle the recalled items.

The recalled product

Product: Bipolar liners and Multipolar cups with the following dimensions in MM (38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 53, 54, 55, 57, 58, 60, 64, 66, 68, 70, 72) and several OD
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implants
Hazard: sterile-barrier-integrity
packaging-validation
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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