FDA Enforcement Class II 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 · Reported May 7, 2014

Enforcement

Recall Number: Z-1515-2014
Event ID: 67885
Classification: Class II
Status: Terminated
Product Type: Devices
Firm: Acumed LLC
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Letter
Report Date: May 7, 2014
Initiation Date: March 26, 2014
Classification Date: April 25, 2014
Termination Date: February 4, 2015
Address: 5885 NW Cornelius Pass Rd, Hillsboro, OR, 97124-9432, United States

Description

Reason

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

Code Info

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.

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.