Zimmer Biomet Recalls Orthopedic Salvage System Hybrid Poly Tibia Components
Zimmer Biomet is recalling 39 units of the Orthopedic Salvage System Hybrid Poly Tibia due to potentially ineffective cleaning processes.
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 source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling 39 units of the Orthopedic Salvage System (OSS) Hybrid Poly Tibia, Item # 151813. The recall was initiated because cleaning processes for these devices may have been ineffective.
The affected products were distributed between June 2016 and February 2019. The recall includes all lots expiring prior to June 30, 2024. These devices were distributed to healthcare facilities in Arizona, California, the District of Columbia, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Jersey, New Mexico, Ohio, Oklahoma, Oregon, South Carolina, and Texas, as well as to Japan and the Netherlands.
Consumers and healthcare providers should contact Zimmer Biomet for instructions on how to return the affected devices.
The recalled product
- Product
- Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151813
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 39
Distribution
Part of a larger recall action
This product is one of 6 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.
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