Z-2222-2019Class II

SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014

Name: Z-2222-2019 SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014
Creator: MicroAire Surgical Instruments, LLC
Published: 2019-06-26
License: https://open.fda.gov/license/

MicroAire Surgical Instruments, LLC / initiated 2019-06-26 / Terminated

FDA source

MicroAire Surgical Instruments, LLC began a recall of SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014 on 2019-06-26. FDA classified it as Class II and gives the reason as "There was a higher than normal incidence rate of the blade not retracting when tightening". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2222-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-26
Posted: 2019-08-08
Terminated: 2020-04-29
Recalling firm: MicroAire Surgical Instruments, LLC
Product: SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014
Product code: HRX Arthroscope
Reason for recall: There was a higher than normal incidence rate of the blade not retracting when tightening.
FDA root cause: Component change control
Action: Urgent Medical Device Recall notification letters were sent to customers on 6/26/19. Additional customers identified later sent letters on 7/17/19. Regardless of the above IFU information, to be on the safe side, MicroAire is performing this recall and asking that you please complete and send back page two of this letter to [email protected] or via fax at 800-648-4309. We will rework the handpiece (by replacing the handpiece head) and return it to you. If you have any questions about this Recall, please contact MicroAire Customer Service at 1-800-722-0822 between the hours of 8:30 AM and 5:00 PM (EST) Monday through Friday.
Quantity in commerce: 103
Distribution: The products were distributed to the following US states: CA, CT, FL, GA, IA, IL, IN, MD, MI, MN, MS, MT, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY. The products were distributed to the following foreign countries: Australia, Czech Republic, France, Germany, and Taiwan.
Product codes and lots: Serial Numbers: 1004 1031 13389 13391 13394 13395 13396 13398 13399 13400 13401 13402 13403 13404 13405 13406 13407 13408 13409 13412 13414 13416 13417 13418 13419 13421 13422 13423 13425 13426 13428 13429 13430 13431 13432 13433 13435 13436 13437 13438 13441 13442 13443 13448 13449 13452 13453 13454 13455 13457 13458 13459 13460 13461 13462 13463 13464 13465 13466 13468 13469 13472 13473 13474 13475 13476 13477 13478 13479 13480 13481 13483 13484 13485 13486 13487 13499 13500 13501 13502 13503 13504 13505 13506 13507 13515 13516 13390 13393 13397 13392 13411 13446 13427 13439 13444 13445 13388 13415 13410 13413 13434 13440

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2222-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2222-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-08

Product code HRX

K912871Class IIInside Job3M Health Care, Ltd. / cleared 1991-08-09

MDM coverage of this record lists here, newest first.

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)