Recall Z-2151-2012 ยท LXH Orthopedic Manual Surgical Instrument
Linvatec Corp. dba ConMed Linvatec
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.
| Date | Aug 6, 2012 (initiated Jul 6, 2012) |
| Status | Terminated |
| 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. |
| Root cause | Process change control |
| Action | The recall is being conducted to the end user level. ConMed Linvatec Urgent Medical Device Recall Notifications were sent by FedEx next day delivery or equivalent method to notify all direct consignees. The notifications identified the affected product along with the reason for the recall and 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 all affected product to ConMed Linvatec and respond using a Reply Form, eve |
| Quantity | 2 |
| Distribution | Worldwide Distribution -- US and Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.