Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1021-2014·Announced 2014-02-26

Zimmer Recalls Knee Implant Components Due to Packaging Validation Issues

Zimmer is recalling specific knee implant components because packaging operations at a 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: This is a voluntary precautionary recall (FDA Class II) based on a validation documentation issue where physical testing confirmed the products met sterile barrier integrity requirements, with no reported illnesses or injuries.

Plain-English summary

Zimmer, Inc. is recalling specific knee implant components, including the I/B II Knee Domed Patella, I/B II Knee Fluted Rod, MGII Knee 10mm Patella, and MGII Knee SLF-Tap Bone Screws. The recall affects 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 showed that the packaging trays met the acceptance criteria for sterile barrier integrity with 99% reliability and a 90% confidence interval, Zimmer decided to recall all non-expired lots from this specific facility to ensure safety.

The affected products were distributed nationwide in the United States and in numerous international countries, including Belgium, Canada, China, France, Germany, India, Japan, and the United Kingdom. Healthcare providers and patients should check their inventory and patient records for these specific product codes and contact Zimmer for further instructions.

The recalled product

Product: I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM PATELLA (2,3 and 4), MGII KNEE SLF-TAP BONE ST
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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