Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0069-2014·Announced 2013-11-06

Zimmer Recalls CPT Femoral Stems Due to Packaging Adhesion Issue

Zimmer, Inc. is recalling CPT Femoral Stems because the low-density polyethylene packaging bags adhere to the polished device surfaces.

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 describes a packaging adhesion issue without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Zimmer, Inc. is recalling CPT Femoral Stems, which are indicated for cemented use in patients suffering from severe hip pain. The recall involves 24,561 units distributed worldwide, including the United States and numerous international markets.

The reason for the recall is that the low-density polyethylene (LDPE) bags used to package the implants adhere to the highly polished surface of the devices. This packaging defect may affect the handling or sterility of the implants, though the source text does not specify reported injuries or illnesses.

Healthcare providers and facilities that have received these devices should contact Zimmer, Inc. for instructions on how to manage the recalled units. Consumers who have had these implants placed should consult their healthcare provider for guidance.

The recalled product

Product: CPT¿ Femoral Stem (CPT 12/14 STEM SIZE 0 COCR; CPT 12/14 SIZE 0 COCR EXT; CPT 12/14 STEM SIZE 1 COCR; CPT 12/14 SIZE 1 COCR EXT CPT 12/14 STEM SIZE 2 COCR; CPT 12/14 SIZE 2 COCR EXT; CPT 12/14 SIZE 2 COCR 180MM; CPT 12/14 SIZE2 COCR XEXT; CPT 12/14 STEM SIZE 3 COCR; CPT 12/14…
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: packaging-defect
Affected units: 24,561

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)

Part Number Range: 00-8114-000/050-00/30

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 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 13 products in this recall →

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