Z-2060-2015 Class II Terminated

Recalled by Zimmer, Inc. — Warsaw, IN

FDA device recall Z-2060-2015 was initiated by Zimmer, Inc. on Jun 17, 2015 and is designated Class II. 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… The recall status is terminated (terminated Mar 15, 2016). Affected quantity: 8.

Recall Details

Product Type
Devices
Report Date
Jul 22, 2015
Initiation Date
Jun 17, 2015
Termination Date
Mar 15, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8

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.

Distribution Pattern

Worldwide distribution. US states of NC and AK; Taiwan, Japan, and Germany.

Code Information

Part 47-2492-320-10; lot 62763724

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-2060-2015
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.