Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1043-2014·Announced 2014-02-26

Zimmer Recalls 3.5 Compression Plates Due to Packaging Validation Issues

Zimmer is recalling 3.5 compression plates sterile packaged at its Puerto Rico facility because packaging operations 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 explicitly states that the products met acceptance criteria for sterile barrier integrity 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 3.5 compression plates (4, 5, 6, 8, 9, and 10-hole configurations). 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 was initiated after Zimmer reviewed historic packaging validations and determined that the packaging operations at this specific 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 lots from this facility as a precaution.

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 patient records for these specific product codes (61270590, 61270591, 61450581, 61270594, 61270595, 61270596) and contact Zimmer for further instructions.

The recalled product

Product: 3.5 COMP PLT, 4 HOLE 3.5 COMP PLT, 5 HOLE 3.5 COMP PLT, 6 HOLE 3.5 COMP PLT, 8 HOLE 3.5 COMP PLT, 9 HOLE 3.5 COMP PLT, 10 HOLE
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implants
Hazard: sterility-compromise
packaging-defect
Affected units: 7,044,680

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

61270590 61270591 61450581 61270594 61270595 61270596

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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