| Class 2 Device Recall Quick Connect Adapter | |
Date Initiated by Firm | October 16, 2009 |
Date Posted | April 15, 2010 |
Recall Status1 |
Terminated 3 on April 11, 2012 |
Recall Number | Z-1399-2010 |
Recall Event ID |
54542 |
Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
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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 OH 44256
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For Additional Information Contact | 330-869-9582 |
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 |
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 |
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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.
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