| | Class 2 Recall
DRLock Bone Fixation Plate systems |  |
| Date Posted |
December 19, 2007 |
| Recall Number |
Z-0136-2008 |
| Product |
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, -12, -14, -16, -18, -20, -22, and -24; All screw caddies and any distal screw and peg inventory not yet added to screw caddies, Ortho Helix Surgical Designs, Inc., Akron, OH |
| Code Information |
LOT NUMBERS: R330, R342, and R343 for styles DRV-002-0R, DRV-002-0L, DRV-002-1R, DRV-002-1L of Bone Fixation Plates-----ALL LOTS of Distal Screws with the following part numbers : DRV-021-24-10; DRV-021-24-12; DRV-021-24-14; DRV-021-24-16; DRV-021-24-18; DRV-021-24-20; DRV-021-24-22; & DRV-021-24-24.-----ALL LOTS of Distal Pegs with the following part numbers : DRV-121-20-10; DRV-121-20-12; DRV-121-20-14; DRV-121-20-16; DRV-121-20-18; DRV-121-20-20; DRV-121-20-22; & DRV-121-20-24.
|
Recalling Firm/
Manufacturer |
OrthoHelix Surgical Designs Inc
1815 W Market St Ste 205
Akron, Ohio 44313-7018 |
Reason for
Recall |
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.
|
| 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 in Commerce |
267 plates/52 DRL System Trays |
| Distribution |
Nationwide; including states of IL, CA, VA, TX, MD, UT, GA, CO, NJ, OH, & WI. |
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