Class 2 Device Recall Locking Clavicle Plate,

• Date Initiated by Firm: February 14, 2008
• Date Posted: September 20, 2008
• Recall Status: Terminated on February 03, 2010
• Recall Number: Z-2128-2008
• Recall Event ID: 48453
• 510(K)Number: K012655
• Product Classification: Bone Fixation - Product Code HWC
• Product: Locking Clavicle Plate, 8 Holes Medium Left. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 8 Holes Medium Left ... REF PL-CL8ML-S LOT W58194".
• Code Information: Work order number/Lot: W58194 (W=work order, ###=sequential number); Expiration date: 2014-11 (Year/Month)
• Recalling Firm/ Manufacturer: Acumed LLC; 5885 NW Cornelius Pass Rd; Hillsboro OR 97124-9370
• For Additional Information Contact: Richard F. Snyder; 503-627-9957 Ext. 1302
• Manufacturer Reason for Recall: Product sterility may be compromised.
• FDA Determined 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 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.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HWC