Recall Z-2156-2008 ยท HBB Motor, Drill, Pneumatic
Medtronic Powered Surgical Solutions
Medtronic Midas Rex Legend tapered dissecting tool, Model F2/8TA23 Medtronic Powered Surgical Solutions, Forth Worth, TX Intended for use in Spinal, Cranial, Orthopedic, General Surgical and Plastic Surgery applications for transection, osteotomy, graft harvesting, bone shaping, laminectomy, entry hole, suture hole, and midface advancement.
| Date | Aug 23, 2008 (initiated May 30, 2008) |
| Status | Terminated |
| Reason | Cutting flute geometry of surgical dissecting tools may be outside of established tolerance. This may lead to reduced cutting performance, inability to perform desired dissection, increased risk of overheating, and potential need for revision surgery. |
| Root cause | Process control |
| Action | Firm notified consignees by Urgent: Medical Device Recall letter sent May 30, 2008. The letter requires consignees to immediately compare their inventory of products against the list provided and quarantine any unused dissecting tools. The letter also states that Medtronic would provide replacement product to match the quantity and type returned by the consignees' institution. |
| Quantity | 1,306 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020069 | MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM Medtronic Midas Rex, Mar 18, 2002 |