Z-0789-2013 Class II Terminated
FDA device recall Z-0789-2013 was initiated by Linvatec Corp. dba ConMed Linvatec on November 15, 2012 and is designated Class II. Reason for recall: ConMed Linvatech recalled one lot of their PopLok bone Punch 3.5mm because the metal shaft diameter is 4.5mm when it should be 3.5mm. The recall status is terminated (terminated May 22, 2013). Affected quantity: 8.
Recall Details
- Product Type
- Devices
- Report Date
- February 13, 2013
- Initiation Date
- November 15, 2012
- Termination Date
- May 22, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8
Product Description
ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch
Reason for Recall
ConMed Linvatech recalled one lot of their PopLok bone Punch 3.5mm because the metal shaft diameter is 4.5mm when it should be 3.5mm.
Distribution Pattern
Worldwide Distribution - USA including California and Internationally to Spain and Korea
Code Information
Lot 256058