Zimmer Biomet, Inc. Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151810 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151810
Brand
Zimmer Biomet, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lot # All lots expiring prior to 06/30/2024 Affected products were distributed between June 2016 and February 2019.
Zimmer Biomet, Inc. is recalling Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151810 due to Cleaning processes potentially being ineffective. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Cleaning processes potentially being ineffective
Recommended Action
Per FDA guidance
Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Certificate of Acknowledgement and send to Corporate Quality. PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com. Surgeon Responsibilities: 1. Review this notification for awareness of the contents. 2. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule. 3. Complete Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed t
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, GA, IL, IN, KY, LA, MD, MA, MN, NJ, NM, NC, OH, OK, OR, SC, TX, DC
Page updated: Jan 10, 2026