03ba9f5b_port___Week_of_August_15__2012__Classification
[Product Type] Devices [Product Description] 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. [Code Info] Lot 318455 [Reason for Recall] 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. [Recalling Firm] Linvatec Corp. dba ConMed Linvatec [Classification] 
Class II
C l a s s I I
C l a s s I I I
C l a s s I
Enforcement Report - Week of August 15, 2012