Z-1848-2015Class II

Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number...

Name: Z-1848-2015 Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number...
Creator: Pega Medical Inc.
Published: 2015-06-15
License: https://open.fda.gov/license/

Orthopediatrics Canada ULC / initiated 2015-06-15 / Terminated

FDA source

Pega Medical Inc. began a recall of Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273 on 2015-06-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1848-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-15
Posted: 2015-06-26
Terminated: 2015-12-29
Recalling firm: Orthopediatrics Canada ULC
Product: Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.
Product code: HWC Screw, Fixation, Bone
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.
FDA 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 in commerce: 4 units
Distribution: US Distribution to 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-1848-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1848-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-06-26

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)