Z-0324-2016Class II

SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw...

Name: Z-0324-2016 SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw...
Creator: Pega Medical Inc.
Published: 2015-10-20
License: https://open.fda.gov/license/

Orthopediatrics Canada ULC / initiated 2015-10-20 / Terminated

FDA source

Pega Medical Inc. began a recall of 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... on 2015-10-20. FDA classified it as Class II and gives the reason as "SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0324-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-20
Posted: 2015-11-20
Terminated: 2016-08-16
Recalling firm: Orthopediatrics Canada ULC
Product: 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 femoral epiphysis (SCFE) in pediatric patients. Orthopedic.
Product code: HWC Screw, Fixation, Bone
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.
FDA 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 [email protected]
Quantity in commerce: 4 units distributed in the US
Distribution: Distributed in the states of FL and TN.
Product codes and lots: Part Number: SCF-MLD265; LOT#: 130703-01 Part Number: SCF-MLD273; LOT#: 130703-02

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0324-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0324-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-02	2015-11-20

Product code HWC

K131591Class IIFree Gliding Slipped Capital Femoral Epiphysis Screw (Scfe)Pega Medical, Inc. / cleared 2013-11-27

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)