FDA Device recall Z-2222-2019
SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014
- FDA Device
- Class II
- terminated
- Published 2019-08-14
On 2019-08-14 the FDA classified a Class II recall of SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014 by Microaire Surgical Instruments, citing there was a higher than normal incidence rate of the blade not retracting when tightening.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2222-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-26 |
| Published | 2019-08-14 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Microaire Surgical Instruments |
| Distribution | 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, WY |
Product
SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014
Reason
There was a higher than normal incidence rate of the blade not retracting when tightening.
Identifiers
| code_info | Serial Numbers: 1004 1031 13389 13391 13394 13395 13396 13398 13399 13400 13401 13402 13403 13404 13405…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2222-2019%22
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