Pega Medical Recalls SCFE Driver Instruments Due to Threaded Shaft Breakage
Pega Medical Inc. is recalling 4 SCFE Driver instruments distributed in Florida and Tennessee because the threaded shaft broke 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 involves a medical device failure (shaft breakage) during a surgical procedure, which presents a risk of harm to patients, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Pega Medical Inc. is recalling 4 units of the SCFE Driver (SCF-MLD273 & SCF-MLD265) instruments. These instruments are used for the insertion of the Free Gliding SCFE Screw System, a temporary implant for stabilizing pediatric femoral neck fractures and slipped capital femoral epiphysis (SCFE) in pediatric patients. The recalled instruments are part of the Free Gliding SCFE Screw System instrument tray and are marked with specific catalogue and lot numbers.
The recall was initiated because the threaded shaft of the SCFE Driver broke close to the knob when manual force was applied during the fixation of the screw. The affected units were distributed in the states of Florida and Tennessee. The specific part numbers and lot numbers involved are SCF-MLD265 (Lot 130703-01) and SCF-MLD273 (Lot 130703-02).
Healthcare providers and facilities that have these specific instruments should stop using them immediately and contact Pega Medical Inc. for instructions on return or replacement. The source text does not report any patient injuries or illnesses associated with this failure.
The recalled product
- 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-
- 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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