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Recall Observatory FDA recall evidence

Device product

ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch

Z-0789-2013

November 15, 2012

Class II

Product summary

Firm
Linvatec Corp. dba ConMed Linvatec
Event
Event 63823
Status
Terminated
Classification
Class II
Quantity
8
Official record key
device-enforcement:Z-0789-2013

Official wording

Reason: ConMed Linvatech recalled one lot of their PopLok bone Punch 3.5mm because the metal shaft diameter is 4.5mm when it should be 3.5mm.

Code information: Lot 256058

Distribution pattern: Worldwide Distribution - USA including California and Internationally to Spain and Korea

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    ConMed Linvatech recalled one lot of their PopLok bone Punch 3.5mm because the metal shaft diameter is 4.5mm when it should be 3.5mm.