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U.S. Department of Health and Human Services

Class 2 Device Recall OsteoClage Stainless Steel Bone Plate

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  Class 2 Device Recall OsteoClage Stainless Steel Bone Plate see related information
Date Initiated by Firm March 26, 2014
Date Posted April 25, 2014
Recall Status1 Terminated 3 on February 04, 2015
Recall Number Z-1515-2014
Recall Event ID 67885
510(K)Number K964500  
Product Classification Pin, fixation, smooth - Product Code HTY
Product The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. .

2.0 mm x 850mm SS Cable/Sleeve; Part Number 01-0020-S
2.0 mm SS Sleeve Only; Part Number 01-0022-S
8, 7 hole, SS compression plate; Part Number 02-2007-S
10, 9 hole, SS compression plate; Part Number 02-2009-S

Product Usage: The Osteo-Clage Stainless Steel Bone Plate is an implantable straight, rigid stainless steel plate. It is used in conjunction with 4.5mm Cortical bone screws to provide compression across bone fractures. The Osteo-Clage Cerclage Wire Crimp sleeve is used in conjunction with the bone plate in cerclage fixation procedures
Code Information 2.0mm x 80mm SS cable/sleeve: Lot # 222078, 232175, 245032, 254368, 261903, 270659, 284155, 297281.  2.0mm SS sleeve only: Lot # 247553, 267469, 280871, 313261.  8, 7 hole SS compression plate: Lot # 300381.  10, 9 hole SS compression plate: Lot # 299641.  
Recalling Firm/
Manufacturer		 Acumed LLC
5885 NW Cornelius Pass Rd
Hillsboro OR 97124-9432
For Additional Information Contact
503-627-9957 Ext. 293
Manufacturer Reason
for Recall		 Manufacturing of these devices with a grade of stainless steel that is not within specifications.
FDA Determined
Cause 2		 Component change control
Action Acumed sent an Urgent Medical Device Recall letter dated March 26, 2014 to all affected customers. The letter identified the affected products, problem and actions to be taken. Customers are instructed to immediately stop using and/or distributing all lots identified in the letter. Return affected products as instructed in the letter. For questions contact Acumed Business Service via email at BusinessService@acumed.net or via phone at 877-627-9957.
Quantity in Commerce 141 units in the US; 294 units outside the US.
Distribution US Nationwide Distribution - in the states of CA, CO, FL, GA, LA, MI, MN, MO, OH, OR, PA, PR, TX, UT, VA, WA and WY. Product was distributed outside the US to: Australia, China, Figi, France, Great Britain, Italy, Japan, Korea, Maylasia, Sweden, South Africa, Spain.
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 = HTY and Original Applicant = ACUMED, INC.
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