FDA Device recall Z-0928-2017
Arthex S3 Arm Sleeve Connector
- FDA Device
- Class II
- terminated
- Published 2017-01-04
On 2017-01-04 the FDA classified a Class II recall of Arthex S3 Arm Sleeve Connector by Allen Medical Systems, citing during use, the unit could separate un-expectantly. This failure would allow the patient's arm to fall out of suspension during a procedure, possibly causing moderate injury to th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0928-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-23 |
| Published | 2017-01-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Allen Medical Systems |
| Distribution | FL |
Product
Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed between March and November 2016.
Reason
During use, the unit could separate un-expectantly. This failure would allow the patient's arm to fall out of suspension during a procedure, possibly causing moderate injury to the patient. This potential defect is not apparent to the user.
Identifiers
| code_info | 499633 499694 499274 499367 499410 499383 499479 499573 499615 499634 499695 499275 499368 499411 499384 499480 499574…499633 499694 499274 499367 499410 499383 499479 499573 499615 499634 499695 499275 499368 499411 499384 499480 499574 499616 499635 499696 499276 499369 499412 499385 499481 499575 499617 499636 499697 499277 499370 499413 499386 499482 499576 499618 499637 499698 499278 499371 499414 499387 499483 499577 499619 499638 499699 499279 499372 499415 499388 499484 499578 499620 499639 499700 499280 499323 499416 499389 499485 499579 499621 499640 499701 499281 499324 499417 499390 499486 499580 499622 499641 499702 499282 499325 499418 499391 499487 499581 499623 499659 499703 499283 499326 499419 499392 499488 499582 499624 499660 499704 499284 499327 499420 499393 499471 499583 499625 499661 499705 499285 499328 499421 499394 499472 499584 499626 499662 499706 499286 499329 499422 499395 499489 499585 499627 499663 499707 499287 499330 499423 499396 499490 499586 499628 499664 499708 499288 499331 499424 499397 499491 499587 499629 499665 499709 499289 499332 499425 49944 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0928-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.