PlainRecalls
FDA Devices Moderate Class II Terminated

ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.

Reported: July 22, 2015 Initiated: June 17, 2015 #Z-2060-2015

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.

Details

Recalling Firm
Zimmer, Inc.
Units Affected
8
Distribution
Worldwide distribution. US states of NC and AK; Taiwan, Japan, and Germany.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.. Recalled by Zimmer, Inc.. Units affected: 8.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 22, 2015. Severity: Moderate. Recall number: Z-2060-2015.