FDA-Device2012-08-15Class II
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.
Linvatec Corp. dba ConMed Linvatec
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.
Sold states
Worldwide Distribution -- US and Korea.
Affected count
2
Manufactured in
11311 Concept Blvd, Largo, FL, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2151-2012Don't want to check this manually?
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