Recall Z-1515-2014
Acumed LLC · initiated March 26, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: 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.
Reason for recall
Manufacturing of these devices with a grade of stainless steel that is not within specifications.
FDA-determined cause: Component change control
Action taken
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.
Details
- Recall number
- Z-1515-2014
- Initiated
- March 26, 2014
- Posted by FDA
- April 25, 2014
- Terminated
- February 4, 2015
- Product code
- HTY – Pin, Fixation, Smooth
- Quantity
- 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.
- Recalling firm
- Acumed LLC, Hillsboro, OR
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1516-2014 Class II | The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is…Certain lots of Acumed Tension Band Pins are being recalled because the implantable product was manufactured… | 03/26/2014Terminated |