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Terminated

Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic manual surgical instrument Item Number: 475665

FDA Recall Z-0595-2020 · Posted None

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2019-10-25
Date Terminated2020-04-30
Product Quantity34 units

Reason for Recall

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

Firm Action

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 [email protected]. 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 [email protected].

Root Cause

Error in labeling

Distribution Pattern

Distribution to US states of CA, FL, IN, MN, MO, NY, and UT, Australia, and New Zealand

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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