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Terminated

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

FDA Recall Z-0136-2008 · Posted 2007-12-19

Recalling FirmOrthoHelix Surgical Designs Inc
Recall StatusTerminated
Product CodeHRS
Date Initiated2007-09-04
Date Terminated2011-05-20
Product Quantity267 plates/52 DRL System Trays

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.

Firm 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.

Root Cause

Component change control

Distribution Pattern

Nationwide; including states of IL, CA, VA, TX, MD, UT, GA, CO, NJ, OH, & WI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K053182DRLOCK DISTAL RADIUS VOLAR SYSTEMOrthohelix Surgical Designs, Inc. · 2006-02-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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