Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265
FDA device recall Z-1848-2015 · posted 2015-06-26 · Terminated
Recall details
- Recalling firm
- Pega Medical Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Reprocessing Controls
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 4 units
- Distribution
- US Distribution to the states of : FL and TN.
- Date initiated
- 2015-06-15
- Date posted
- 2015-06-26
- Date terminated
- 2015-12-29
- Location
- Laval, Canada
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE) (K131591) | Pega Medical, Inc. | 2013-11-27 |