Recall Z-2140-2008 ยท JDQ Cerclage, Fixation
Acumed LLC
Osteo-Clage Cable System Package Assembly (01-0001-S). Product labeled in part, "2.0mm x 850 mm CoCr Cable / Sleeve... REF 01-0001-S LOT W59192... Acumed 5885 NW Cornelius Pass Road Hilsboro, OR 97124-9432 ".
| Date | Aug 22, 2008 (initiated Mar 28, 2008) |
| Status | Terminated |
| Reason | Cables of incorrect diameter were used in product assembly, resulting in the sleeve not being able to bind to the cable after crimping. |
| Root cause | Employee error |
| Action | On 3/28/08, the firm sent an Urgent Notification letter to their consignees. The letter explained the issue and requested the customers return the product to Acumend. On 7/16/08, the firm sent a 2nd notification, via mail, to thier customers. The Urgent Notice: Device Recall 2nd Notification, advised customers of the recall, the hazard and requested customers to return existing product to Acumed. |
| Quantity | 50 units |
| Distribution | Nationwide Distribution --- including states of AR, CA, PA, GA, KS, MO, and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K921480 | OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM Acu-Med, Inc., Jun 26, 1992 |