FDA Enforcement
Class II
Terminated
Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CCD Left Ti-6Al-4V Alloy- intended for temporary fracture fixation and stabilization of the bone Item Number: 47-2493-211-11
Recall: Z-1792-2021
·
Reported June 9, 2021
Enforcement
- Recall Number
- Z-1792-2021
- Event ID
- 87924
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Zimmer GmbH
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 9, 2021
- Initiation Date
- May 7, 2021
- Classification Date
- June 4, 2021
- Termination Date
- April 18, 2024
- Address
- Sulzerallee 8, Winterthur, N/A, Switzerland
Description
Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CCD Left Ti-6Al-4V Alloy- intended for temporary fracture fixation and stabilization of the bone Item Number: 47-2493-211-11
Reason
Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree
Code Info
Lot Number: 3020731 UDI: (01) 0088902498880 (17) 300131 (10) 3020731
Distribution
CA, GA, KY, MD Foreign: Australia Brazil, Canada Netherlands
Quantity
8 units