Left Locking Proximal Metatarsal Wedge Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Left Locking Proximal Metatarsal Wedge Plate... REF 70-0010-S... LOT W58118".
This recall has been terminated (originally issued September 20, 2008).
- Company
- Acumed Llc
- Recall Initiated
- February 14, 2008
- Posted
- September 20, 2008
- Terminated
- February 3, 2010
- Recall Number
- Z-2111-2008
- Quantity
- 3 pcs
- Firm Location
- Hillsboro, OR
- Official Source
- View on FDA website ↗
Reason for Recall
Product sterility may be compromised.
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.
Lot / Code Info
Work order number/Lot: W58118 (W=work order, ###=sequential number); Expiration date: 2014-11 (Year/Month)
Root Cause
Packaging process control
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.