The Recall Desk
HighFDA (Devices)·Z-1014-2018·Announced 2018-03-21

Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue

Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE packaging may leave residue on the polished surfaces.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where packaging residue may remain on the implant, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.

Plain-English summary

Zimmer Biomet, Inc. is recalling 13,227 units of the Bipolar Metal Shell 48 MM OD, a component used in total hip replacement. The recall covers specific lots of highly polished hip and knee implants distributed in the United States and internationally.

The recall was initiated because the LDPE bag packaging may adhere to the highly polished surface of the implants. 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 nationwide in the US and in countries including 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 affected implants.

The recalled product

Product
BIPOLAR METAL SHELL 48 MM OD Use of the MultiPolar Bipolar Cup is indicated in: Total hip replacement
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: 00-5001-048-00 Lot Number: 62202263

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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Same manufacturer · Zimmer Biomet, Inc.

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