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U.S. Department of Health and Human Services

Class 2 Device Recall MAXLOCK EXTREME EXTREMITY PLATING SYSTEM

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 Class 2 Device Recall MAXLOCK EXTREME EXTREMITY PLATING SYSTEMsee related information
Date Initiated by FirmAugust 22, 2011
Date PostedJanuary 11, 2012
Recall Status1 Terminated 3 on February 19, 2012
Recall NumberZ-0421-2012
Recall Event ID 60454
510(K)NumberK102156 
Product Classification Plate, fixation, bone - Product Code HRS
ProductMAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY. Product Usage: Variable Angle technology in MTP, TMT, MFT, MXL, DFX, and EDL plates are indicated for fractures, fusions and osteotomies for small bones in the hand, wrist, foot and ankle in both pediatric and adult patients. Variable Angle Technology in MXL and CLA plates are indicated for the fractures, fusions, and osteotomies of the clavicle and small bones in the hand, wrist, foot and ankle.
Code Information Lot # 1364, 1731, 1862, Model # VAR-031-35-10, Model # VAR-031-35-12, Model # VAR-031-35-14, Model # VAR-031-35-16, Model # VAR-031-35-18, Model # VAR-031-35-20, Model # VAR-031-35-22, Model # VAR-031-35-24, Model #, VAR-031-35-26, Model # VAR-031-35-28, Model # VAR-031-35-30 & Lot # 1365011, 1365012, Model #, MXL-032-35 and Model # VAR-032-35
Recalling Firm/
Manufacturer		 Orthohelix Surgical Designs Inc
1065 Medina Rd., Suite 500
Medina OH 44256
For Additional Information ContactKristin Wolff
330-247-1445
Manufacturer Reason
for Recall		The firm discovered a testing protocol error, in both dynamic and static cantilever comparative testing, during the initial comparative testing.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOrthohelix Surgical Designs Inc. sent an URGENT RECALL NOTIFICATION letter dated August 22, 2011 to all affected customers. The letter identified the affected products, the problem, and the actions to be taken. Customers were instructed to immediately inventory, remove and return the recalled product to the firm via FedEx or any shipping method with tracking capability. Customers were also requested to notify any affected user facilities of the recall. For any questions call 330-247-1444 or 330-247-1445.
Quantity in Commerce2,722 units
DistributionNationwide Distribution (USA) - including the states of: CA, CO, CT, FL, GA, IA, IL, KY, LA, MD, MI, MO, NC, NJ, NM, NY, OH, OK, PA, SD, TN, TX, UT, VA, WA, WI and WY.
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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