Locking Clavicle Plate, 8 Holes Medium Right. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR

FDA device recall Z-2129-2008 · posted 2008-09-20 · Terminated

Recall details

Recalling firm

Acumed LLC

Reason for recall

Product sterility may be compromised.

Action taken

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 products to Acumed... If you further distributed this product, please notify those customers/consignees of this recall. This recall is to be extended to the user level." The letter includes an effectiveness form to be filled out by the customer and returned to Acumed.

Root cause

Packaging process control

Status

Terminated

Product code

HWC

Quantity affected

10 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.

Date initiated

2008-02-14

Date posted

2008-09-20

Date terminated

2010-02-03

Location

Hillsboro, OR

Related 510(k) clearances