Z-1515-2014 Class II Terminated
FDA device recall Z-1515-2014 was initiated by Acumed LLC on March 26, 2014 and is designated Class II. Reason for recall: Manufacturing of these devices with a grade of stainless steel that is not within specifications. The recall status is terminated (terminated February 4, 2015). Affected quantity: 141 units in the US; 294 units outside the US..
Recall Details
- Product Type
- Devices
- Report Date
- May 7, 2014
- Initiation Date
- March 26, 2014
- Termination Date
- February 4, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 141 units in the US; 294 units outside the US.
Product Description
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
Reason for Recall
Manufacturing of these devices with a grade of stainless steel that is not within specifications.
Distribution Pattern
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.
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.