Z-2151-2012 Class II Terminated
FDA device recall Z-2151-2012 was initiated by Linvatec Corp. dba ConMed Linvatec on July 6, 2012 and is designated Class II. 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. The recall status is terminated (terminated November 21, 2013). Affected quantity: 2.
Recall Details
- Product Type
- Devices
- Report Date
- August 15, 2012
- Initiation Date
- July 6, 2012
- Termination Date
- November 21, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
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.
Distribution Pattern
Worldwide Distribution -- US and Korea.
Code Information
Lot 318455