Dual Mobility Vivacit-E Bearing, Model Number 110031009
FDA Recall Z-0057-2021 · Posted None
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Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeLPH
Date Initiated2020-08-14
Date Terminated2022-06-09
Product Quantity31
Reason for Recall
The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm.
Firm Action
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 [email protected]. 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 [email protected].
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 [email protected].
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
Root Cause
Under Investigation by firm
Distribution Pattern
Products were distributed to the following US states: FL, ID, IL, IN, KY, MA, MD, MI, MN, NC, NJ, OH, OR, PA, SC, TX, UT, VA, WI, and WV.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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