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U.S. Department of Health and Human Services

Class 2 Device Recall DRLock Bone Fixation Plate systems

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 Class 2 Recall
DRLock Bone Fixation Plate systems
see related information
Date Posted December 19, 2007
Recall Status1 Open
Recall Number Z-0136-2008
Recall Event ID 44883
Product Classification Plate, Fixation, Bone - Product Code HRS
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
Code Information 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.
Recalling Firm/
Manufacturer
OrthoHelix Surgical Designs Inc
1815 W Market St Ste 205
Akron, Ohio 44313-7018
Manufacturer 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.
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.
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
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