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Linvatec Corp. dba ConMed Linvatec recalls PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd. Hermiankatu
Recalled August 15, 2012 · FDA recall Z-2151-2012 · Linvatec Corp.
Hazard
ConMed Linvatec recalled one lot of their PopLok bone Punch 3.5MM because the metal shaft diameter is 4.5mm when it should have been 3.5mm. · FDA Class II
Units
2
Sold at
Worldwide Distribution -- US and Korea.
Description
ConMed Linvatec recalled one lot of their PopLok bone Punch 3.5MM because the metal shaft diameter is 4.5mm when it should have been 3.5mm.
Product
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.
Manufacturer(s)
Linvatec Corp. dba ConMed Linvatec
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →