Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0399-2019·Announced 2018-11-14

Zimmer Biomet Recalls StageOne Hip Cement Spacer Molds

Zimmer Biomet is recalling 72 units of StageOne Hip cement spacer molds due to a potential for comingling of 43MM and 51MM sizes.

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, and the hazard is a potential comingling of mold sizes without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Zimmer Biomet, Inc. is recalling 72 units of StageOne Hip cement spacer molds, Models 431207 and 431209. These single-use, sterile disposable molds are made of medical-grade silicone with a 316L stainless steel reinforcement stem and are designed to be filled with polymethylmethacrylate/gentamicin bone cement for use in two-stage hip joint procedures.

The recall was initiated because there is a potential for comingling of the 43MM and 51MM molds. The affected lots are Item Number 431207, Lot # 705550, and Item Number 431209, Lots # 705570 and 705580. The products were distributed nationwide in the states of Arizona, Florida, Michigan, Ohio, Virginia, and Wisconsin.

Healthcare facilities and consumers who have these specific products should stop using them and contact Zimmer Biomet, Inc. for further instructions on how to return or dispose of the recalled items.

The recalled product

Product: StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use cement spacer molds are sterile disposables made of medical grade silicone with a 316L stainless steel reinforcement stem. They are designed to be filled with polymethylmethacrylate/gentamicin bone…
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Orthopedic Implants
Hazard: mis-labeling
product-mix-up
Affected units: 72

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 (3)

Item Number 431207 Lot # 705550
UDI - (01)00880304447141(17)270916(10)705570 Lot # 705580
UDI - (01)00880304447141(17)270916(10)705580

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Same manufacturer · Zimmer Biomet, Inc.

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Same hazard · mis labeling