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.
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 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.
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 · contamination
See all →- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAvid Medical Recalls Robotic Prostatectomy Packs for Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls 23 ABD Hysterectomy Kits Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
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
- HighBiomet Recalls Knee Prosthesis Components Due to Endotoxin Concerns
FDA (Devices) · 2020-06-03
- ModerateZimmer Biomet Recalls Orthopedic Stems Due to Potential Labeling Error
FDA (Devices) · 2018-12-19
- HighBiomet OSS Polyethylene Tibial Bushing Recalled for Sterile Seal Breach
FDA (Devices) · 2020-12-23