SCFE Driver recall
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…
Why was SCFE Driver recalled?
SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Number: SCF-MLD265; LOT#: 130703-01 Part Number: SCF-MLD273; LOT#: 130703-02
- 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…
- Recalling firm
- Pega Medical Inc.
- Quantity
- 4 units distributed in the US
- Distribution
- Distributed in the states of FL and TN.
- Recall date
- December 2, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)