Recall Z-0008-2012 ยท MRW System, Facet Screw Spinal Device
Osteomed, Lp
OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Arapaho Road, Addison, Texas 75001
| Date | Oct 4, 2011 (initiated Jun 7, 2011) |
| Status | Terminated |
| Reason | Two of the Implant Driver Assembly tips were reported to break during surgery. |
| Root cause | Device Design |
| Action | OsteoMed LP sent an Urgent --Product Recall letter dated June 7, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory immediately for affected inventory and promptly return any affected inventory to: OsteoMed LP Attan: Rebecca Ellis 3885 Arapaho Road Addison, Texas 75001 If the customer further distributed any of the affected product customers were instructed to immediately contact their accounts and advise them of the recall situation and have them return any devi |
| Quantity | 20 units |
| Distribution | Nationwide Distribution including PA, TX, CA, IL IA, FL, CT, and MO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102438 | PRIMALOK FACET FIXATION SYSTEM Osteomed LP, Sep 30, 2010 |