Zimmer Biomet Recalls Orthopedic Salvage System Hybrid Poly Tibia Components
Zimmer Biomet is recalling 28 Orthopedic Salvage System Hybrid Poly Tibia units because cleaning processes may be ineffective. The products were distributed in the US and internationally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (ineffective cleaning) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria.
Plain-English summary
Zimmer Biomet, Inc. is recalling 28 units of the Orthopedic Salvage System (OSS) Hybrid Poly Tibia, Item # 151811. The recall is being conducted because the cleaning processes used 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. Distribution occurred in the United States (AZ, CA, DC, GA, IL, KY, LA, MA, MD, MN, NC, NJ, NM, OH, OK, OR, SC, TX) as well as in Japan and the Netherlands.
This is an FDA Class II recall. 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 # 151811
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 28
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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