Recall Z-2153-2008 ยท HRS Plate, Fixation, Bone
Acumed LLC
Acu-Loc Distal Radius Plate, Standard, Left. Product labeled in part, " Acu-Loc Distal Radius Plate, Standard, Left... PL-DR50L W48003... Manufactured or Distributed by: Acumed LLC Hillsboro, OR ".
| Date | Aug 28, 2008 (initiated Jun 29, 2007) |
| Status | Terminated |
| Reason | Plates are incorrectly laser marked. The PL-DR50L plates are incorrectly laser marked with PL-DR70L. |
| Root cause | Process control |
| Action | The firm issued an Urgent Notification: Product Removal letter on 6-29-2007. The notification was reportedly sent by either FAX or e-mail. The notification informed consignees to remove the plates from their inventory and return them to Acumed. The notification did not include any instructions for a sub-recall. On 6/13/08, the firm sent a second Urgent Notification: Product Removal letter. This letter describes the product as PL-DR50L - Lot Code - W48003, explains the problem and asks customers to return product to Acumed. |
| Quantity | 51 pieces |
| Distribution | Worldwide Distribution --- including USA and countries of South Africa, Italy, Finland, and Brazil. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012655 | CONGRUENT BONE PLATE SYSTEM Acu Med, Inc., Nov 7, 2001 |