Zimmer Biomet Recalls Orthopedic Salvage System Hybrid Poly Tibia Components
Zimmer Biomet is recalling 29 Orthopedic Salvage System Hybrid Poly Tibia units because cleaning processes may be ineffective. The recall covers units distributed in the US, Japan, and the Netherlands.
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is described as a potential ineffectiveness of cleaning processes, which fits the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 29 units of the Orthopedic Salvage System (OSS) Hybrid Poly Tibia, Item # 151810. The recall was initiated because cleaning processes for these devices may be ineffective. The affected products were distributed between June 2016 and February 2019 and include all lots expiring prior to 06/30/2024.
The devices were distributed to healthcare facilities in 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 should stop using the affected devices and contact Zimmer Biomet for instructions on return or replacement. Patients who have received these implants should consult their healthcare provider for guidance.
The recalled product
- Product
- Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151810
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 29
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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