Recall Z-1792-2021— Zimmer GmbH
Class II · Terminated
Class II FDA medical device recall by Zimmer GmbH, initiated 2021-05-07, terminated 2024-04-18. It names one FDA 510(k) clearance: K091566. Product: 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.
- Recalling firm
- Zimmer GmbH
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-05-07
- Terminated
- 2024-04-18
- Firm location
- Winterthur, Switzerland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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 for recall
Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree
Data sourced from openFDA. This site is unofficial and independent of the FDA.