Recall Z-0136-2008 ยท HRS Plate, Fixation, Bone
OrthoHelix Surgical Designs Inc
DRL System Trays comprised of DRLock Bone Fixation Plates, Pegs, and Screw Systems: Four Plate Styles include: Part Numbers: DRV-002-0L Fixed Short Left Plate, DRV-002-0R , Fixed Short Right Plate, DRV-002-1L, Fixed Standard Left Plate, and DRV-002-1R, Fixed Standard Right Plate; Distal Screw Part Numbers: DRV-021-24-10, -12, -14, -16, -18, -20, -22 and -24; Distal Peg Part Number: DRV-121-20-10,
| Date | Dec 19, 2007 (initiated Sep 4, 2007) |
| Status | Terminated |
| Reason | Seat/Fit problems: The heads of the distal screws/pegs rest above the surface of the distal plate after the screws/pegs are fully tightened. |
| Root cause | Component change control |
| Action | On 9/4/2007, OrthoHelix mailed an Important Recall Notification letters via certified mail to all direct accounts. The notification instructed all accounts to examine their inventory and return all recalled product, identified within the notification, to OrthoHelix for replacement. |
| Quantity | 267 plates/52 DRL System Trays |
| Distribution | Nationwide; including states of IL, CA, VA, TX, MD, UT, GA, CO, NJ, OH, & WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053182 | DRLOCK DISTAL RADIUS VOLAR SYSTEM Orthohelix Surgical Designs, Inc., Feb 27, 2006 |