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Recall Observatory FDA recall evidence

Device product

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

Z-2060-2015

June 17, 2015

Class II

Product summary

Firm
Zimmer, Inc.
Event
Event 71530
Status
Terminated
Classification
Class II
Quantity
8
Official record key
device-enforcement:Z-2060-2015

Official wording

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.

Code information: Part 47-2492-320-10; lot 62763724

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.