Zimmer Biomet, Inc. Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bone Saw Cam Assembly was labeled and etched as a 14 MM but measured as a 13 MM cam

Recommended Action

Per FDA guidance

Zimmer Biomet issued URGENT MEDICAL DEVICE RECALL letter via FedEx and email on 10/25/19. The letter identifies the reason for recall, health risk and action to take: Review this notification and ensure that affected personnel are aware of the contents. 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. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. Questions call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Alternatively, your questions may be emailed to corporateQuality.PostMarket@zimmerbiomet.com.

Distribution

As reported by FDA

CA, FL, IN, MN, MO, NY, UT