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U.S. Department of Health and Human Services

Class 2 Device Recall Quick Connect Adapter

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 Class 2 Recall
Quick Connect Adapter
see related information
Date Posted April 15, 2010
Recall Status1 Terminated on April 11, 2012
Recall Number Z-1399-2010
Recall Event ID 54542
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Quick Connect Adapter Model #CSS-QA-Adapter MaxTorque(R) Maxtorque Quick Connect Lot #s: 1014001 & 1101011, QTY 1 NON STERILE MAT:17-4PH The intended use: Used to stabilize and aid in the fixation of fractures, fusions, and osteotomies.
Code Information Model #CSS-QA-Adapter Lot #: GB759, GB-924, 1014001 & 1101011
Recalling Firm/
Manufacturer
Orthohelix Surgical Designs Inc
1065 Medina Rd., Suite 500
Medina, Ohio 44256
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
The adapters are able to come apart when a retaining ring in the proximal end of the adapter can dislodge from the retaining ring groove and the two ends of the adapter fall apart and are unable to be reassembled without special tools and knowledge of the instrument. Also the adapters have a wobble between the two ends. This is caused when the distal and proximal ends of the adapter assembly were
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action Two "IMPORTANT RECALL NOTICE" letters, one dated October 16, 2009, and the second letter dated November 19, 2009, were sent to the customers. The letters described the product, problem and action to be taken by the customers. The customer are requested to discontinue use of the adapters and return them to the firm, Orthohelix Surgical Designs. The firm will replace the adapters as soon as possible. Should you have any questions about the systems please contact Kristin Wolff at 330-247-1445 or Jim Bragg at 330-247-1444.
Quantity in Commerce 127 pieces
Distribution Nationwide distribution: CA, CO, FL, GA, IL, KY, MD, MI, MO, MS, NC, NJ, NM, NY, OH, OR, PA, SD, TN, TX, VA, WA , and 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
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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