Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1027-2014·Announced 2014-02-26

Zimmer Recalls Pressfit Femoral Stems Due to Packaging Validation Issues

Zimmer, Inc. is recalling 7,044,680 units of Pressfit Femoral Stems 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, but the source text explicitly states that the product met acceptance criteria for sterile barrier integrity and no illnesses or injuries are reported. This fits the rubric for a voluntary precautionary recall with low-risk contamination concerns.

Plain-English summary

Zimmer, Inc. is recalling 7,044,680 units of the Pressfit Femoral Stem FX 16 X 1. The recall affects lots that have not expired and were sterile packaged in the Building 1 packaging operations at the Zimmer Manufacturing B.V. facility in Ponce, Puerto Rico. The product was distributed nationwide in the United States and in numerous countries worldwide, including Belgium, Canada, China, France, Germany, India, Italy, 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 showed that the packaging tray configurations met the acceptance criteria for sterile barrier integrity, Zimmer decided to recall the affected lots as a precautionary measure.

Healthcare providers and patients should check their inventory and records for the affected product codes 60621428 and 60667768. If the product is identified, it should be removed from use and returned to Zimmer, Inc. in accordance with their recall instructions.

The recalled product

Product: PRESSFIT FEM ST FX 16 X 1
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)

60621428 60667768

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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