Zimmer Biomet Recalls Orthopedic Salvage System Hybrid Poly Tibia Components
Zimmer Biomet is recalling 19 units of Orthopedic Salvage System Hybrid Poly Tibia components because cleaning processes may be ineffective.
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is described as a potential ineffectiveness in cleaning processes, which aligns with the rubric for moderate severity involving theoretical or low-risk contamination issues without reported harm.
Plain-English summary
Zimmer Biomet, Inc. is recalling 19 units of the Orthopedic Salvage System (OSS) Hybrid Poly Tibia, Item # 151815. The recall is due to concerns that 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. These devices were distributed to 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.
Healthcare providers and patients should contact Zimmer Biomet for instructions on how to return the affected devices or obtain replacements. Patients who have already received these implants should consult their healthcare provider for guidance.
The recalled product
- Product
- Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151815
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 19
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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