Home / Recalls / MicroAire Surgical Instruments, LLC / Z-2294-2016

Z-2294-2016 Class II Terminated

Recalled by MicroAire Surgical Instruments, LLC — Charlottesville, VA

Recall Details

Product Type
Devices
Report Date
August 3, 2016
Initiation Date
May 6, 2016
Termination Date
August 12, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
29

Product Description

Endotine Transbleph 3.5 (CFD-080-0167)

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 Pattern

The product was distributed in the United States and Sweden

Code Information

Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373

Other recalls by MicroAire Surgical Instruments, LLC

  • Z-1975-2025 Class II — Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx B (May 7, 2025)
  • Z-2222-2019 Class II — SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part n (June 26, 2019)
  • Z-2107-2018 Class II — MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, Smar (April 19, 2018)
  • Z-0412-2018 Class II — SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This pro (May 22, 2017)
  • Z-1407-2017 Class II — MicroAire K-Wires (February 21, 2017)
  • Z-1834-2016 Class II — Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professio (March 11, 2016)
  • Z-1328-2016 Class II — MicroAire PAL¿ Cannula Product Usage - Power Aspiration Device (February 8, 2016)
  • Z-1323-2016 Class II — MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula (February 8, 2016)
  • Z-2822-2015 Class II — ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump. Medical use. (June 12, 2015)
  • Z-2821-2015 Class II — ASP-1020 LipoTower with Aspiration Pump. Medical use. (June 12, 2015)