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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 Recall
MAXLOCK EXTREME EXTREMITY PLATING SYSTEM
see related information
Date Posted January 11, 2012
Recall Status1 Terminated on February 19, 2012
Recall Number Z-0421-2012
Recall Event ID 60454
Premarket Notification
510(K) Number
K102156 
Product Classification Plate, Fixation, Bone - Product Code HRS
Product MAXLOCK 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, Ohio 44256
For Additional Information Contact Kristin 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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Orthohelix 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 Commerce 2,722 units
Distribution Nationwide 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 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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