Reported Aug 14, 2019 · Terminated

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

MicroAire Surgical Instruments, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: MicroAire Surgical Instruments, LLC · 3590 Grand Forks Blvd · Charlottesville, VA · 22911-9006

Is this the product you have?

  • SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014
Lot codes and dates
  • Serial Numbers

    103 of 103 codes

    • 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
Amount recalled
103

Where it was sold

Why it was recalled

There was a higher than normal incidence rate of the blade not retracting when tightening.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 29, 2020 · Data as of Sep 19, 5:32 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.