Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1053-2018·Announced 2018-03-21

Zimmer Biomet Recalls Patella Femoral Joint Implants Due to Packaging Residue

Zimmer Biomet is recalling 13,227 patella femoral joint implants because LDPE bag packaging may leave residue on the polished surface.

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 defect (residue) without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Zimmer Biomet, Inc. is recalling 13,227 units of the ZIMMER PATELLA FEMORAL JOINT implant. The product is indicated for the treatment of osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint. The specific code identified in the recall is 00-5926-014-02 Knee PFJ FEM, CEMENTED, SZ 4, RIGHT.

The recall is due to a packaging issue where the LDPE bag may adhere to the highly polished surface of the implant. This adhesion can leave residue or material from the bag on the implant after it is removed from the packaging.

The affected products were distributed worldwide, including nationwide in the United States and in countries such as Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE. Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the return or replacement of these devices.

The recalled product

Product: ZIMMER PATELLA FEMORAL JOINT¿ Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint.
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Orthopedic Implants
Hazard: packaging-residue
Affected units: 13,227

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 (4)

00-5926-014-02 Knee PFJ FEM
CEMENTED
SZ 4
RIGHT

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 48 recalled by Zimmer Biomet, 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 48 products in this recall →

Same manufacturer · Zimmer Biomet, Inc.

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Same hazard · packaging residue