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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 Device Recall DRLock Bone Fixation Plate systemssee related information
Date Initiated by FirmSeptember 04, 2007
Date PostedDecember 19, 2007
Recall Status1 Terminated 3 on May 20, 2011
Recall NumberZ-0136-2008
Recall Event ID 44883
510(K)NumberK053182 
Product Classification Bone Fixation Plate - Product Code HRS
ProductDRL 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 OH 44313-7018
For Additional Information Contact
330-869-9568
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.
FDA Determined
Cause 2		Component change control
ActionOn 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 Commerce267 plates/52 DRL System Trays
DistributionNationwide; including states of IL, CA, VA, TX, MD, UT, GA, CO, NJ, OH, & WI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HRS
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