Recall Z-0421-2012 ยท HRS Plate, Fixation, Bone
Orthohelix Surgical Designs Inc
MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY. Product Usage: Variable Angle technology in MTP, TMT, MFT, MXL, DFX, and EDL plates are indicated for fractures, fusions and osteotomies for small bones in the hand, wrist, foot and ankle in both pediatric and adult patients. Variable Angle Technology in MXL and CLA plates are indicated for the fractures, fusions, and oste
| Date | Jan 11, 2012 (initiated Aug 22, 2011) |
| Status | Terminated |
| Reason | The firm discovered a testing protocol error, in both dynamic and static cantilever comparative testing, during the initial comparative testing. |
| Root cause | Nonconforming Material/Component |
| Action | Orthohelix Surgical Designs Inc. sent an URGENT RECALL NOTIFICATION letter dated August 22, 2011 to all affected customers. The letter identified the affected products, the problem, and the actions to be taken. Customers were instructed to immediately inventory, remove and return the recalled product to the firm via FedEx or any shipping method with tracking capability. Customers were also requested to notify any affected user facilities of the recall. For any questions call 330-247-1444 or 330-247-1445. |
| Quantity | 2,722 units |
| Distribution | Nationwide Distribution (USA) - including the states of: CA, CO, CT, FL, GA, IA, IL, KY, LA, MD, MI, MO, NC, NJ, NM, NY, OH, OK, PA, SD, TN, TX, UT, VA, WA, WI and WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102156 | MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWS Orthohelix Surgical Designs, Inc., Sep 30, 2010 |