The Recall Desk
ModerateFDA (Devices)·Z-1015-2018·Announced 2018-03-21

Zimmer Biomet Recalls Hip Implants Due to Packaging Residue

Zimmer Biomet is recalling specific hip implants because LDPE packaging may leave residue on the polished surface.

What this means for you

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, and the hazard involves packaging residue on a medical device without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Zimmer Biomet, Inc. is recalling 13,227 units of CPT 12/14 COCR REVISION SIZE 2 180MM hip prostheses. The affected items are semi-constrained, metal/polymer, porous uncemented hip implants. The recall is due to a packaging issue where the LDPE bag may adhere to the highly polished surface of the implant, leaving residue or material behind after the implant is removed from the bag.

The affected product is identified by Item Number 00-8114-002-18 and Lot Number 61750651. The distribution was worldwide, including the United States (nationwide) and numerous international locations such as Argentina, Australia, Brazil, and Canada.

This recall is classified as Class II by the FDA. Healthcare providers and facilities should check their inventory for the specific item and lot numbers listed and contact Zimmer Biomet for instructions on how to proceed.

The recalled product

Product
CPT 12/14 COCR REVISION SIZE 2 180MM prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Manufacturer
Zimmer Biomet, Inc.
Category
Medical Device — Orthopedic Implants
Hazard
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 (1)

  • Item Number: 00-8114-002-18 Lot Number: 61750651

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 →

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