FDA Recall Terminated

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.

Recall: Z-3081-2011 · Initiated July 6, 2011

Recall

Recall Number: Z-3081-2011
Event Number: 59462
Firm: Orthohelix Surgical Designs Inc
FEI Number: 3000718467
Product Code: HRS
Status: Terminated
Root Cause: Nonconforming Material/Component
Initiated: July 6, 2011
Posted: August 29, 2011
Terminated: September 10, 2012
Address: 1065 Medina Rd., Suite 500, Medina, OH, 44256

Description

Reason

The surgical tray does not meet our Instruction for Use (IFU) for dry time requirement.

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 system normally. No further actions or precautions are needed. Distributors were also asked to notify their customers of the recall. If you have any questions, please call 330-247-1444 or 330-247-1445.

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.

Quantity

61 trays