Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1029-2018·Announced 2018-03-21

Zimmer Biomet Recalls Versus 8 Inch Beaded Hip Implants Due to Packaging Residue

Zimmer Biomet is recalling 13,227 Versus 8 Inch Beaded 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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a packaging defect that may leave residue on the implant, which fits the criteria for a moderate severity recall involving low-risk contamination or voluntary precautionary measures without reported harm.

Plain-English summary

Zimmer Biomet, Inc. is recalling 13,227 units of the Versus 8 Inch Beaded hip prosthesis. The recall covers various sizes and configurations of the semi-constrained, metal/polymer, porous uncemented hip implants. The products were distributed nationwide in the United States and in 24 other countries, including Argentina, Australia, Brazil, and Canada.

The recall was initiated because the LDPE bag packaging used for these highly polished implants may adhere to the implant surface. This adhesion can leave residue or material from the LDPE bag on the implant after it is removed from the packaging. The source text does not report any specific illnesses, injuries, or deaths associated with this issue.

Healthcare providers and patients should be aware that the packaging material may contaminate the implant surface. The source text does not provide specific instructions for consumers or patients on how to handle the recalled devices, but the recall is managed by the U.S. Food and Drug Administration under recall number Z-1029-2018.

The recalled product

Product: VERSYS 8 INCH BEADED FC 12X200MM STR STD BODY/NECK 13X200MM STR STD BODY/NECK 14X200MM STR STD BODY/NECK REV 13.5X200MM BWD LT 15X200MM STR STD BODY/NECK REV 13.5X200MM BWD RT REV 15.0X200MM BWD LT REV 15.0X200MM BWD RT REV 16.5X200MM BWD LT REV 16.5X200MM BWD RT…
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Orthopedic Implants
Hazard: packaging-residue
contamination
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.

See all →

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Same hazard · packaging residue