Zimmer Biomet Recalls Orthopedic Salvage System Hybrid Poly Tibia Components
Zimmer Biomet is recalling 23 Orthopedic Salvage System Hybrid Poly Tibia units because cleaning processes may be ineffective. The products were distributed to 18 US states, Japan, and the Netherlands.
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 3/5 (High).
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 the source text does not report any illnesses or injuries. According to the rubric, a Class II recall without reported hospitalizations or injuries falls under the 'High' severity category, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 23 units of the Orthopedic Salvage System (OSS) Hybrid Poly Tibia, Item # 151812. The recall was initiated because the cleaning processes for these devices may be ineffective. The affected products were distributed between June 2016 and February 2019.
The recall covers all lots expiring prior to June 30, 2024. The devices were distributed to the following US states: Arizona, California, District of Columbia, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Jersey, New Mexico, Ohio, Oklahoma, Oregon, South Carolina, and Texas. Additionally, the products were distributed to Japan and the Netherlands.
Healthcare providers and facilities that have received these products should contact Zimmer Biomet for instructions on how to return or replace the affected units. Patients who have had these implants should consult their healthcare provider for guidance.
The recalled product
- Product
- Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151812
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 23
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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