The Recall Desk
ModerateFDA (Devices)·Z-1016-2018·Announced 2018-03-21

Zimmer Biomet Recalls Hip Implants Due to Packaging Residue

Zimmer Biomet is recalling specific hip prostheses because LDPE packaging may leave residue on the polished implant 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, 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 CPT 12/14 COCR Size 0 STD hip prostheses. The recall involves specific item and lot numbers distributed worldwide, including the United States and 23 other countries.

The recall is issued 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.

Healthcare providers and facilities that have received these specific hip prostheses should stop using them and contact Zimmer Biomet for further instructions. Consumers who have had these implants placed should consult their healthcare provider regarding the potential presence of packaging residue.

The recalled product

Product
CPT 12/14 COCR SIZE 0 STD 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: 00-8114-000-00 Lot Numbers: 61779346 61783708

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 →

Related recalls

Same manufacturer · Zimmer Biomet, Inc.

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Same hazard · packaging residue

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