Recall Z-1916-2018 ยท HXX Screwdriver
Synthes (USA) Products LLC
Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation.
| Date | May 4, 2018 |
| Status | Terminated |
| Reason | The adapter may demonstrate a degradation of function as the final products were assembled with ball bearings of high carbon content that is likely to rust prematurely. |
| Root cause | Component design/selection |
| Action | An Urgent Medical Device Recall Notification letters dated May 4, 2018, were distributed to customers. The letter requests that customers take the following actions: Potential Patient Impact: The subject, Torque Limiting Handle, may demonstrate a degradation of function with the adapter collar sticking, and/or not retaining the mating adapter male shaft of the driver component. In addition, the ball bearings may corrode over time causing a failure in the torque limiting feature. The following potential scenarios could occur: " Malunion/nonunion and device loosening if there is a degradatio |
| Quantity | 50 |
| Distribution | USA (nationwide) Distribution to the states of : AK, CA, FL, ID, IN, KS, KY, LA, MD, MI, MT, NC, NJ, NY, OH, OK, PA, SD, TN, TX, UT, WI, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.