Zimmer Biomet, Inc. Dual Mobility Vivacit-E Bearing, Model Number 110031009 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Dual Mobility Vivacit-E Bearing, Model Number 110031009
Brand
Zimmer Biomet, Inc.
Lot Codes / Batch Numbers
Lot Number 64755636
Products Sold
Lot Number 64755636
Zimmer Biomet, Inc. is recalling Dual Mobility Vivacit-E Bearing, Model Number 110031009 due to The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm.
Recommended Action
Per FDA guidance
Urgent Medical Device Recall notification letters dated 8/14/20 were sent to customers. 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 Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form will 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. If the product has been implanted, Zimmer Biomet recommends assessing the patient with imaging and monitoring the patient for the potential health risks. 3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. 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
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
FL, ID, IL, IN, KY, MD, MA, MI, MN, NJ, NC, OH, OR, PA, SC, TX, UT, VA, WV, WI
Page updated: Jan 10, 2026