Z-2294-2016Class II

Endotine Transbleph 3.5 (CFD-080-0167)

Name: Z-2294-2016 Endotine Transbleph 3.5 (CFD-080-0167)
Creator: MicroAire Surgical Instruments, LLC
Published: 2016-05-06
License: https://open.fda.gov/license/

MicroAire Surgical Instruments, LLC / initiated 2016-05-06 / Terminated / root cause: labeling and UDI

FDA source

MicroAire Surgical Instruments, LLC began a recall of Endotine Transbleph 3.5 (CFD-080-0167) on 2016-05-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2294-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-06
Posted: 2016-07-27
Terminated: 2016-08-12
Recalling firm: MicroAire Surgical Instruments, LLC
Product: Endotine Transbleph 3.5 (CFD-080-0167)
Product code: HWC Screw, Fixation, Bone
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).
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: 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.
Quantity in commerce: 29
Distribution: The product was distributed in the United States and Sweden
Product codes and lots: Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2294-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2294-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-27

Product code HWC

K042796Class IIEndotine Transbleph 3.0/3.5 DeviceCoapt Systems, Inc. / cleared 2004-11-05

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)