Recall Z-2603-2014 ยท HRS Plate, Fixation, Bone
Wright Medical Technology, Inc.
CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 25mm, REF 40240225, 1 EACH, Rx ONLY, NON STERILE Orthopedic
| Date | Sep 8, 2014 (initiated Jul 30, 2014) |
| Status | Terminated |
| Reason | Plates manufactured from an incorrect raw material. |
| Root cause | Device Design |
| Action | Wright Medical sent an Urgent Medical Device Recall letter dated July 25, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory for the affected product and immediately quarantine all affected product and return to Wright Medical as soon as possible. For return instructions customers were instructed to contact Customer Service at 800-238-7117. Customers were also asked to complete the attached response form, confirming receipt of the notice and the status of the produ |
| Quantity | 400 units |
| Distribution | Worldwide Distribution - USA (Nationwide) and Internationally to Canada Australia, Great Britain, Germany, Spain, Netherlands, France. |
| FDA record | Open on fda.gov |