SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This inst
FDA device recall Z-0324-2016 · posted 2015-11-20 · Terminated
Recall details
- Recalling firm
- Pega Medical Inc.
- Reason for recall
- SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw.
- Action taken
- 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
- Root cause
- Unknown/Undetermined by firm
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 4 units distributed in the US
- Distribution
- Distributed in the states of FL and TN.
- Date initiated
- 2015-10-20
- Date posted
- 2015-11-20
- Date terminated
- 2016-08-16
- 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 |