Recall Z-2151-2012— Linvatec Corp. dba ConMed Linvatec
Class II · Terminated
Class II FDA medical device recall by Linvatec Corp. dba ConMed Linvatec, initiated 2012-07-06, terminated 2013-11-21. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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
- Status
- Terminated
- Initiated
- 2012-07-06
- Terminated
- 2013-11-21
- Firm location
- Largo, FL, United States
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.