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 Reduction Forcep*, 2 Hohmann Retractors *, 1 Ratchet Handle*, 1 Periosteal Elevator*, 1 Dingman Eleva Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 Eleva
Brand
OrthoHelix Surgical Designs Inc
Lot Codes / Batch Numbers
Tray kit (case) set number: ''BAA'', ''BAB'', ''BAC'', ''BAD'', ''BAE'', ''BAF'', ''BAH''
Products Sold
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)
OrthoHelix Surgical Designs Inc is recalling DRLock Volar Plate Screw System, Model #DVR-900. The product is a kit contained in an aluminum tray due to The 48 distal locking-screws (ranging from 10-24mm) contained in the kit are not within established specifications, specifically the minor diameter of. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The recalling firm contacted all consignees by phone on or about 8/3/06.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CO, IN, OH, SC, TX
Page updated: Jan 10, 2026