—#177793

Product

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

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lot Numbers: 334360, 366680, 366670 UDI: (01)00880304386587(17)280805(10)334360 (01)00880304386587(17)280530(10)366680 (01)00880304386587(17)280530(10)366670

Why it was recalled

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

Root cause (FDA determination)

Error in labeling

Action the firm took

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.

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

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

Timeline

Recall initiated: 2019-10-25
Terminated: 2020-04-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #177793. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.