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U.S. Department of Health and Human Services

Class 3 Device Recall DRLock Volar Plate Screw System, model DVR900

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 Class 3 Recall
DRLock Volar Plate Screw System, model DVR900
see related information
Date Posted January 19, 2007
Recall Status1 Open
Recall Number Z-0349-2007
Recall Event ID 36843
Premarket Notification
510(K) Number
K053182 
Product Classification Plate, Fixation, Bone - Product Code HRS
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.
Code Information 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)
Recalling Firm/
Manufacturer
OrthoHelix Surgical Designs Inc
1815 W Market St Ste 205
Akron, Ohio 44313-7018
For Additional Information Contact Rick L. Kovach
330-869-9562
Manufacturer 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 Determined
Cause 2
DESIGN: Device Design
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = ORTHOHELIX SURGICAL DESIGNS, INC.
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