Endotine Transbleph 3.5 (CFD-080-0167)
This recall has been terminated (originally issued May 6, 2016).
- Recall Initiated
- May 6, 2016
- Terminated
- August 12, 2016
- Recall Number
- Z-2294-2016
- Quantity
- 29
- Firm Location
- Charlottesville, VA
- Official Source
- View on FDA website ↗
Reason for Recall
MicroAire has initiated a limited recall (29 Units)on the Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373, due to minor mislabeling ( the front label is correct, but the side label lists an incorrect part number, i.e. CFD-080-0177).
Distribution
The product was distributed in the United States and Sweden
Lot / Code Info
Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373
Root Cause
Labeling Change Control
Action Taken
The firm is sending recall letters to the customers who have received the Endotine Transbleph 3.5 (CFD-080-0167), lot #285373. Letters sent by UPS to expedite the delivery.
More recalls by Microaire Surgical Instruments, Llc
Brand Name: SmartRelease ESTR (Endoscopic soft tissue release
system), Onyx Blade Assembly; altern...
Jun 12, 2025
SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 830...
Jun 26, 2019
MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece,...
May 25, 2018
SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE
This product line is intended...
May 22, 2017
MicroAire K-Wires
Mar 3, 2017