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U.S. Department of Health and Human Services

Class 2 Device Recall Left Locking Dorsal 1st MTP Fusion Plate

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  Class 2 Device Recall Left Locking Dorsal 1st MTP Fusion Plate see related information
Date Initiated by Firm February 14, 2008
Date Posted September 20, 2008
Recall Status1 Terminated 3 on February 03, 2010
Recall Number Z-2113-2008
Recall Event ID 48453
510(K)Number K033639  
Product Classification Bone Fixation - Product Code HWC
Product Left Locking Dorsal 1st MTP Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Left Locking Dorsal 1st MTP Fusion Plate... REF 70-0012-S... LOT W58120".
Code Information Work order number/Lot: W58120 (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 2		 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 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.
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 and Original Applicant = ACUMED LLC
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