FDA Medical Device Recalls (openFDA)
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, -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
- Recall number
- Z-0136-2008
- Recalling firm
- OrthoHelix Surgical Designs Inc
- 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
- Status
- Terminated
- Initiated
- 2007-09-04
- Posted
- 2007-12-19
- Terminated
- 2011-05-20
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K053182"]
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 3000718467
- Firm city
- Akron
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28