Z-0136-2008

DRL System Trays comprised of DRLock Bone Fixation Plates, Pegs, and Screw Systems: Four Plate Styles...

Name: Z-0136-2008 DRL System Trays comprised of DRLock Bone Fixation Plates, Pegs, and Screw Systems: Four Plate Styles...
Creator: OrthoHelix Surgical Designs Inc
Published: 2007-09-04
License: https://open.fda.gov/license/

TORNIER Inc. / initiated 2007-09-04 / Terminated

FDA source

OrthoHelix Surgical Designs Inc began a recall of 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... on 2007-09-04. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0136-2008
Status: Terminated
Initiated: 2007-09-04
Posted: 2007-12-19
Terminated: 2011-05-20
Recalling firm: TORNIER 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
Product code: HRS Plate, Fixation, Bone
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.
FDA 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 in commerce: 267 plates/52 DRL System Trays
Distribution: Nationwide; including states of IL, CA, VA, TX, MD, UT, GA, CO, NJ, OH, & WI.
Product codes and lots: 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.

Product code HRS

K053182Class IIDrlock Distal Radius Volar SystemOrthohelix Surgical Designs, Inc. / cleared 2006-02-27

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)