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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:111312

PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd. Hermiankatu 6-8L 33720 Tampere, FINLAND***Rx Only***ConMed Linvatec 11311 Concept Blvd Largo, FL 33773-4908 USA***Made in USA***" Intended Use: Bone Punch.

Official recall number

Z-2151-2012

Evidence summary

Product code
LXH
Recall status
Terminated
Event initiated
July 06, 2012
Root cause
Process change control
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2151-2012

Field note

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