Acumed LLC recalls The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS Cable/S

Recalled May 7, 2014 · FDA recall Z-1515-2014 · Acumed

Hazard

Manufacturing of these devices with a grade of stainless steel that is not within specifications. · FDA Class II

Units

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

Sold at

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.

Description

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

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

Manufacturer(s)

Acumed LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →