Recall Z-0789-2013 ยท LXH Orthopedic Manual Surgical Instrument
Linvatec Corp. dba ConMed Linvatec
ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch
| Date | Feb 5, 2013 (initiated Nov 15, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Employee error |
| Action | ConMed Linvatech issued a "URGENT MEDICAL DEVICE RECALL NOTIFICATION" to its customers on November 15, 2012 for a recall that was conducted at the end user/distributor level. All recall notifications were sent FedEx next day delivery or equivalent method to notify all direct consignees. The notifications identified the affected product along with reason for the recall health risk. All accounts were asked to immediately check their facility for the affected product, stop using any of the product with specified lot number, and to segregate the product. The letter also asked customers to return |
| Quantity | 8 |
| Distribution | Worldwide Distribution - USA including California and Internationally to Spain and Korea |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.