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Z-0057-2021Class II

Dual Mobility Vivacit-E Bearing, Model Number 110031009

Zimmer GmbH / initiated 2020-08-14 / Terminated / root cause: labeling and UDI
FDA source (opens on fda.gov)

Zimmer Biomet, Inc. began a recall of Dual Mobility Vivacit-E Bearing, Model Number 110031009 on . FDA classified it as Class II and gives the reason as "The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0057-2021
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Zimmer GmbH
Product
Dual Mobility Vivacit-E Bearing, Model Number 110031009
Product code
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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.
Root cause tag
labeling and UDI
FDA root cause
Under Investigation by 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
Quantity in commerce
31
Distribution
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.
Product codes and lots
Lot Number 64755636

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0057-2021
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0057-2021Class IITerminatedVoluntary: Firm initiated