Zimmer Biomet, Inc.: 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 rei

Is my product affected?

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 cement, or equivalent, by inj

• UPC 00880304447165
• UPC 00880304447141

Check against the official notice below — it lists the full affected range.

What happened

Zimmer Biomet, Inc. is recalling StageOne Hip cement spacer molds (models 431207 and 431209) distributed nationwide in Arizona, Florida, Michigan, Ohio, Virginia, and Wisconsin. The single-use sterile silicone molds with stainless steel components pose a potential hazard because the 43MM and 51MM mold sizes could be mixed up or confused with each other. A total of 72 units across multiple lots are affected.

The recall involves specific lot numbers: Item 431207 Lot #705550; Item 431209 Lot #705570 and Lot #705580. The source document does not specify a remedy or corrective action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

There is a potential for comingling of the 43MM and 51 MM molds

Details from the source

Reason for recall: There is a potential for comingling of the 43MM and 51 MM molds Distribution: US Nationwide Distribution in the states of: AZ, FL, MI, OH, VA & WI Quantity: 72 units Lot/code info: Item Number 431207 Lot # 705550, UDI - (01)00880304447165(17)270927(10)705550 Item Number 431209 Lot # 705570, UDI - (01)00880304447141(17)270916(10)705570 Lot # 705580, UDI - (01)00880304447141(17)270916(10)705580

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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