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Recall Observatory FDA recall evidence

Device product

A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument.

Z-2072-2015

June 17, 2015

Class II

Product summary

Firm
Biomet, Inc.
Event
Event 71549
Status
Terminated
Classification
Class II
Quantity
223
Official record key
device-enforcement:Z-2072-2015

Official wording

Reason: Medium Bone Plate Forceps was assembled with the incorrect grip arm tip. Potential that the surgeon will be unable to provisionally clamp the plate to the patient's bone.

Code information: Part Number: 816301006 Lot Numbers: 099216, 093776, 093717, 093716, 088526, 081179, 072525, 072524

Distribution pattern: Domestic: TX NJ, NC, KY, MA, SD, MO, AL, IN, GA, AR International: Netherlands, Japan, Costa Rica

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Medium Bone Plate Forceps was assembled with the incorrect grip arm tip. Potential that the surgeon will be unable to provisionally clamp the plate to the patient's bone.