Recalls / —

—#183647

Product

Dual Mobility Vivacit-E Bearing, Model Number 110031009

FDA product code

LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K190656

Affected lot / code info

Lot Number 64755636

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm

Zimmer Biomet, Inc.

Address

1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

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.

Timeline

Recall initiated

2020-08-14

Terminated

2022-06-09

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #183647. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.