Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1019-2018·Announced 2018-03-21

Zimmer Biomet Recalls Hip Implants Due to Packaging Residue

Zimmer Biomet is recalling 13,227 hip implants because LDPE 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. The hazard involves packaging residue on a medical device, which is a quality defect without reported injuries or illnesses in the source text, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Zimmer Biomet, Inc. is recalling 13,227 CPT 12/14 COCR Size 2 Std hip prostheses. These are semi-constrained, metal/polymer, porous uncemented implants. The recall covers specific lot numbers and item number 00-8114-002-00.

The recall was initiated because the LDPE bag packaging for these highly polished implants may adhere to the surface. 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 in the United States and numerous international countries such as Argentina, Australia, Brazil, and Canada. The source text does not specify instructions for consumers or healthcare providers regarding the next steps for these recalled devices.

The recalled product

Product: CPT 12/14 COCR SIZE 2 STD prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Orthopedic Implants
Hazard: packaging-residue
foreign-material
Affected units: 13,227

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