FDA Enforcement
Class II
Terminated
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.
Recall: Z-2151-2012
·
Reported August 15, 2012
Enforcement
- Recall Number
- Z-2151-2012
- Event ID
- 62665
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Linvatec Corp. dba ConMed Linvatec
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 15, 2012
- Initiation Date
- July 6, 2012
- Classification Date
- August 6, 2012
- Termination Date
- November 21, 2013
- Address
- 11311 Concept Blvd, Largo, FL, 33773-4908, United States
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
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.
Code Info
Lot 318455
Distribution
Worldwide Distribution -- US and Korea.
Quantity
2