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U.S. Department of Health and Human Services

Class 2 Device Recall Orthopedic implant

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  Class 2 Device Recall Orthopedic implant see related information
Date Initiated by Firm March 28, 2008
Date Posted August 22, 2008
Recall Status1 Terminated 3 on February 03, 2010
Recall Number Z-2140-2008
Recall Event ID 48465
510(K)Number K921480  
Product Classification Fixation Cerclage - Product Code JDQ
Product Osteo-Clage Cable System Package Assembly (01-0001-S). Product labeled in part, "2.0mm x 850 mm CoCr Cable / Sleeve... REF 01-0001-S LOT W59192... Acumed 5885 NW Cornelius Pass Road Hilsboro, OR 97124-9432 ".
Code Information Work order number/Lot: W59192 (W=work order, ###=sequential number); Expiration date: 2015-01 (Year/Month)
Recalling Firm/
Manufacturer		 Acumed LLC
5885 NW Cornelius Pass Rd
Hillsboro OR 97124-9432
For Additional Information Contact Richard F. Snyder
503-627-9957 Ext. 293
Manufacturer Reason
for Recall		 Cables of incorrect diameter were used in product assembly, resulting in the sleeve not being able to bind to the cable after crimping.
FDA Determined
Cause 2		 Employee error
Action On 3/28/08, the firm sent an Urgent Notification letter to their consignees. The letter explained the issue and requested the customers return the product to Acumend. On 7/16/08, the firm sent a 2nd notification, via mail, to thier customers. The Urgent Notice: Device Recall 2nd Notification, advised customers of the recall, the hazard and requested customers to return existing product to Acumed.
Quantity in Commerce 50 units
Distribution Nationwide Distribution --- including states of AR, CA, PA, GA, KS, MO, and TN.
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 = JDQ and Original Applicant = ACU-MED, INC.
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