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.
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 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 cem
- Manufacturer
- Zimmer Biomet, Inc.
- 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
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