Zimmer Biomet Recalls Orthopedic Salvage System Hybrid Poly Tibia Components
Zimmer Biomet is recalling 30 Orthopedic Salvage System Hybrid Poly Tibia units because cleaning processes may be ineffective.
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. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is described as a potential ineffectiveness of cleaning processes rather than a confirmed high-risk pathogen or structural failure.
Plain-English summary
Zimmer Biomet, Inc. is recalling 30 units of the Orthopedic Salvage System (OSS) Hybrid Poly Tibia, Item # 151814. The recall was initiated because cleaning processes for these devices may be ineffective.
The affected products were distributed between June 2016 and February 2019. The recall includes all lots expiring prior to June 30, 2024. The devices were distributed to the following US states: AZ, CA, DC, GA, IL, KY, LA, MA, MD, MN, NC, NJ, NM, OH, OK, OR, SC, and TX. The products were also distributed to Japan and the Netherlands.
Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151814
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 30
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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