Z-0349-2007

DRLock Volar Plate Screw System, Model #DVR-900. The product is a kit contained in an aluminum tray case that...

Name: Z-0349-2007 DRLock Volar Plate Screw System, Model #DVR-900. The product is a kit contained in an aluminum tray case that...
Creator: OrthoHelix Surgical Designs Inc
Published: 2006-08-03
License: https://open.fda.gov/license/

TORNIER Inc. / initiated 2006-08-03 / Terminated

FDA source

OrthoHelix Surgical Designs Inc began a recall of 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... on 2006-08-03. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0349-2007
Status: Terminated
Initiated: 2006-08-03
Posted: 2007-01-19
Terminated: 2012-09-10
Recalling firm: TORNIER Inc.
Product: 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 Reduction Forcep*, 2 Hohmann Retractors *, 1 Ratchet Handle*, 1 Periosteal Elevator*, 1 Dingman Elevator *, 1 K & K Elevator *, four Driver tips *, five drill guides*, 2-1.6 Drill Bits *, 2-2.3 Drill Bits *, 1 Plate Holder Verbruge *, 2 Depth Gages *, 6 K wires.
Product code: HRS Plate, Fixation, Bone
Reason for recall: 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.
FDA root cause: Other
Action: The recalling firm contacted all consignees by phone on or about 8/3/06.
Quantity in commerce: 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.
Product codes and lots: Tray kit (case) set number: ''BAA'', ''BAB'', ''BAC'', ''BAD'', ''BAE'', ''BAF'', ''BAH'', and ''BAJ''. (The distal locking-screws contained in the kit are identified with lot numbers S104 and S200)

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)