Pega Medical Recalls SCFE Drivers Due to Handle Detachment Risk
Pega Medical Inc. is recalling four units of SCFE Drivers because the handle may detach from the shaft during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a mechanical failure that could cause injury during surgery, but no specific injuries or hospitalizations are reported in the source text.
Plain-English summary
Pega Medical Inc. is recalling four units of Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System. The affected units have catalogue numbers SCF-MLD265 and SCF-MLD273. The recall involves specific lot numbers: 130703-01 for part number SCF-MLD265 and 130703-02 for part number SCF-MLD273.
The recall is being conducted because the handle of the instruments may detach from the shaft if high torques are applied in counter-clockwise rotation. This defect poses a risk of injury to patients or healthcare providers during surgical procedures.
The affected products were distributed in the United States to the states of Florida and Tennessee. Healthcare facilities and consumers who possess these specific units should stop using them immediately and contact Pega Medical Inc. for instructions on return or replacement.
The recalled product
- Product
- Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.
- Manufacturer
- Pega Medical Inc.
- Hazard
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Part Number: SCF-MLD265
- LOT#: 130703-01. Part Number: SCF-MLD273
- LOT#: 130703-02.
Distribution
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