Recall Z-0349-2007 ยท HRS Plate, Fixation, Bone
OrthoHelix Surgical Designs Inc
DRLock Volar Plate Screw System, Model #DVR-900. The product is a kit contained in an aluminum tray case that contains the following: IMPLANTS: 6 stainless steel plates (2-lefts, 2-rights, and 1-right long and 1-right left), 48 distal locking-screws (ranging from 10-24mm), 32 distal locking pegs, 36 proximal locking screws, 24 proximal non-locking screws. INSTRUMENTS: 2 Bending Pliers*, 1 Bone Re
| Date | Jan 19, 2007 (initiated Aug 3, 2006) |
| Status | Terminated |
| Reason | The 48 distal locking-screws (ranging from 10-24mm) contained in the kit are not within established specifications, specifically the minor diameter of the screws are undersized. |
| Root cause | Other |
| Action | The recalling firm contacted all consignees by phone on or about 8/3/06. |
| Quantity | 180 |
| Distribution | The product was distributed to 5 consignees located in the U.S.: Archway Medical, Columbia, SC; Gulf Coast Surgical, Stafford, TX; Vaugham Medical, Wheat Ridge, CO; Belemy Medical, Cleveland, OH; and Crystal Clinic, Akron, OH. |
| 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 |