Recall Z-2060-2015— Zimmer, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer, Inc., initiated 2015-06-17, terminated 2016-03-15. It names one FDA 510(k) clearance: K083497. Product: ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.. Reason: A single distributed ZNN Greater Trochanter Femoral Nail may have been dented. Potential for fatigue of implant prior to sufficient fracture healing, which may result in need for implant removal and revision of fracture fixation to assure proper healing and avoid fracture malunion or nonunion..
- Recalling firm
- Zimmer, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-06-17
- Terminated
- 2016-03-15
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
1 on FDA's record- K083497 — ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMORAL NAILS
K-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
ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.
Reason for recall
A single distributed ZNN Greater Trochanter Femoral Nail may have been dented. Potential for fatigue of implant prior to sufficient fracture healing, which may result in need for implant removal and revision of fracture fixation to assure proper healing and avoid fracture malunion or nonunion.
Data sourced from openFDA. This site is unofficial and independent of the FDA.