Class 2 Device Recall Acumed Tension Band Pin

• Date Initiated by Firm: March 26, 2014
• Date Posted: April 25, 2014
• Recall Status: Terminated on February 04, 2015
• Recall Number: Z-1516-2014
• Recall Event ID: 67885
• 510(K)Number: K931244
• Product Classification: Plate, fixation, bone - Product Code HRS
• Product: The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available in lengths between 35mm and 90mm. It is to be used in conjunction with commonly used orthopedic wire.; ; 50.0 mm Tension Band Pin; Part Number 30-0097; 70.0 mm Tension Band Pin; Part Number 30-0098; 90.0 mm Tension Band Pin; Part Number 30-0099; 50.0 mm Tension Band Kit; Part Number TB-1550K-S; 70.0 mm Tension Band Kit; Part Number TB-1570K-S; 90.0 mm Tension Band Kit; Part Number TB-1590K-S; ; Product Usage: Acumed Tension Band Pin is intended to be used with orthopedic wire to address malleolar, patella, and olecranon fractures in tension band wiring procedures. This device is not intended for usage in the spine.
• Code Information: 50.0 mm Tension Band Pin: Lot 243639 70.0 mm Tension Band Pin: Lots 241127, 242707, 243325, 243948. 90.0 mm Tension Band Pin: Lots 241128. 242708, 243327, 243949. 50.0 mm Tension Band Kit: Lots 216769, 217002, 217941, 219145, 219402, 222732, 223007, 224312, 229889, 232575, 235490, 237772, 244800, 246204, 247056. 70.0 mm Tension Band Kit: Lots 210290, 211349, 214574, 215405, 217004, 218273, 219230, 220978, 221503, 223008, 223477, 224066, 225554, 227193, 229394, 230287, 230952, 231971, 233742, 235502, 237773, 240512, 241185, 243617, 243945, 244801, 246777, 246779, 246938, 247108, 247109, 247493. 90.0 mm Tension Band Kit: Lots 215053, 217005, 218600, 218700, 221465, 222731, 223009, 223756, 225555, 228951, 231573, 236969, 237774, 243620, 244802, 246939, 246990, 247381.
• Recalling Firm/ Manufacturer: Acumed LLC; 5885 NW Cornelius Pass Rd; Hillsboro OR 97124-9432
• For Additional Information Contact: 503-627-9957 Ext. 293
• Manufacturer Reason for Recall: Certain lots of Acumed Tension Band Pins are being recalled because the implantable product was manufactured with a grade of stainless steel that is not within specifications.
• FDA Determined Cause: Component change control
• 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 BusinessService@acumed.net or via phone at 877-627-9957.
• Quantity in Commerce: 2544 unit in the US and 3584 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HRS and Original Applicant = ACUMED, INC.