Recall Z-1848-2015 ยท HWC Screw, Fixation, Bone
Pega Medical Inc.
Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.
| Date | Jun 26, 2015 (initiated Jun 15, 2015) |
| Status | Terminated |
| Reason | SCFE Drivers of the Free-Gliding SCFE Screw System are recalled because the handle of the instruments may detach from the shaft if high torques are applied in counter-clockwise rotation. |
| Root cause | Reprocessing Controls |
| Action | Pega Medical sent an Urgent Field Safety-Recall letter via email on June 15, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Advise on action to be taken by the customer: Identify the device with the same catalogue number and lot number Return the device to Pega Medical Inc. to the address shown below using the FedEx account. For further questions please call the firm at 450-688-5144 x. 242. |
| Quantity | 4 units |
| Distribution | US Distribution to the states of : FL and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131591 | FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE) Pega Medical, Inc., Nov 27, 2013 |