FDA Recall Terminated

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

Recall: Z-1515-2014 · Initiated March 26, 2014

Recall

Recall Number: Z-1515-2014
Event Number: 67885
Firm: Acumed LLC
FEI Number: 1000125930
Product Code: HTY
Status: Terminated
Root Cause: Component change control
Initiated: March 26, 2014
Posted: April 25, 2014
Terminated: February 4, 2015
Address: 5885 NW Cornelius Pass Rd, Hillsboro, OR, 97124-9432

Description

Reason

Manufacturing of these devices with a grade of stainless steel that is not within specifications.

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 [email protected] or via phone at 877-627-9957.

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.

Quantity

141 units in the US; 294 units outside the US.