Recall Z-1399-2010 ยท LXH Orthopedic Manual Surgical Instrument
Orthohelix Surgical Designs Inc
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.
| Date | Apr 15, 2010 (initiated Oct 16, 2009) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.