Recall Z-3081-2011 ยท HRS Plate, Fixation, Bone
Orthohelix Surgical Designs Inc
Mini MaxLock Extreme Plating System Case & Tray, Model Number(s): MXM-901, Product Usage: The Mini MaxLock Extreme Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments. Surgical Case and Tray Delivery System used to house plating and screw orthopedic implant system and instrumentation.
| Date | Aug 29, 2011 (initiated Jul 6, 2011) |
| Status | Terminated |
| Reason | The surgical tray does not meet our Instruction for Use (IFU) for dry time requirement. |
| Root cause | Nonconforming Material/Component |
| Action | Orthohelix Surgical Designs Inc sent a RECALL NOTIFICATION letter dated July 6, 2011 and an UPDATED URGENT RECALL 2ND NOTIFICATION letter dated July 13, 2011 to all affected customers. The letter identified the recalled product, the problem, and the Field Correction actions to be taken. Customers were instructed to remove the blue rubber mat in the utility bay of the tray base immediately, tag the mat with the tray number, and return it to recalling firm immediately. The letter states once customers have removed the blue rubber mat from the tray base, they may continue to use the tray and s |
| Quantity | 61 trays |
| Distribution | USA Nationwide Distribution including the states of: AR, AZ, CA, CO, FL, GA, IL, IN, KY, MA, MD, MI, MO, NC, NE, NJ, NM, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, WI & WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101962 | MINI MAXLOCK EXTREME PLATING SYSTEM Orthohelix Surgical Designs, Inc., Sep 27, 2010 |