Recall Z-0324-2016 ยท HWC Screw, Fixation, Bone
Pega Medical Inc.
SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This instrument is included in the Free Gliding SCFE Screw System instrument tray. This instrument is marked with the catalogue number and lot number. The Free-Gliding SCFE Screw System is a temporary implant for stabilization of pediatric femoral neck fractures and slipped capital f
| Date | Nov 20, 2015 (initiated Oct 20, 2015) |
| Status | Terminated |
| Reason | SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw. |
| Root cause | Unknown/Undetermined by firm |
| Action | The firm sent the Urgent Field Safety Notice-Recalls to US consignees via email. Consignees are advised to return affected devices back to the firm. Customer with questions can contact Enrique Garcia at 450-688-5144 ext. 242 or send email to egarcia@pegamedical.com |
| Quantity | 4 units distributed in the US |
| Distribution | Distributed in 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 |