Recall Z-2114-2008 ยท HWC Screw, Fixation, Bone
Acumed LLC
Left Locking 1st MTP Revision Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Left Locking 1st MTP Revision Fusion Plate... REF 70-0018-S... LOT W58121".
| Date | Sep 20, 2008 (initiated Feb 14, 2008) |
| Status | Terminated |
| Reason | Product sterility may be compromised. |
| Root cause | Packaging process control |
| Action | The firm issued four separate Urgent Notification: Product Removal were issued by the firm on 2-14-2008, 2-20-2008, 2-26-2008, and 3-25-2008 for the issue of poorly sealed sterile pouches. The notifications were reportedly sent by either FAX or e-mail. The firm explained the issue and requested customers to return the specified products. On 7/16/08, the firm issued a second recall notification to their customers. This letter informed the customer of the recall, listed the products affected, stated the reason for the recall, tells customers, "return existing inventories of the recalled produ |
| Quantity | 3 pcs |
| Distribution | Worldwide Distribution ---- USA including states of WA, NE, NC, UT, FL, CA, OR, TX, NY, IL, OH, MT, and Puerto Rico, and countries of United Kingdom, Australia, and Greece. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033639 | ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM Acumed, LLC, Jan 15, 2004 |