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.
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 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.
See all 6 products in this recall →Related recalls
Same manufacturer · Zimmer Biomet, Inc.
See all →- HighZimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
- ModerateZimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
- HighZimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11
Same hazard · infection risk
See all →- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Sterilization Monitoring Failure
FDA (Devices) · 2026-10-14
- HighFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighRecall of Medical Convenience Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- SevereFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighMedline Neurological Surgery Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-09-30
Similar recalls
- ModerateZimmer Biomet Recalls Mislabelled Orthopedic Salvage System Tibial Bodies
FDA (Devices) · 2017-02-08
- ModerateZimmer Biomet Recalls Orthopedic Salvage System Porous Stem Due to Labeling Error
FDA (Devices) · 2018-12-19
- ModerateZimmer Biomet Recalls Orthopedic Salvage System Locking Collars
FDA (Devices) · 2018-05-02
- ModerateZimmer Biomet Recalls Orthopedic Stems Due to Potential Labeling Error
FDA (Devices) · 2018-12-19
- ModerateBiomet Recalls Orthopedic Implants Due to Screw Hole Mismatch
FDA (Devices) · 2018-04-04
- HighBiomet Recalls Knee Prosthesis Components Due to Endotoxin Concerns
FDA (Devices) · 2020-06-03