FDA Medical Device Recalls (openFDA)
Pega Medical Inc.: Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.
- Recall number
- Z-1848-2015
- Recalling firm
- Pega Medical Inc.
- Product
- Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.
- Status
- Terminated
- Initiated
- 2015-06-15
- Posted
- 2015-06-26
- Terminated
- 2015-12-29
- Reason
- 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.
- 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
- 4 units
- Distribution
- US Distribution to the states of : FL and TN.
- Lot, serial or model codes
- Part Number: SCF-MLD265, LOT#: 130703-01. Part Number: SCF-MLD273, LOT#: 130703-02.
- 510(k) numbers
- ["K131591"]
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 3000327445
- Firm city
- Laval
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28