Recall Z-0928-2017
Allen Medical Systems, Inc. · initiated November 23, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed between March and November 2016.
Codes / lots: 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 499440 499492 499588 499630 499666 499710 499290 499333 499426 499441 499493 499589 499552 499667 499298 499291 499334 499427 499442 499494 499590 499553 499668 499299 499292 499335 499428 499443 499495 499592 499554…
Reason for recall
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.
FDA-determined cause: Under Investigation by firm
Action taken
The firm's customer was notified of the recall via letter on November 23, 2016. They were asked to take the following actions: 1. Immediately remove from service your Arthrex S3 Arm Sleeve Connector (AR-1650-02). All serial numbers are impacted. 2. Please follow the included instructions for the return of all S3 Arm Sleeve Connectors (AR-1650-02). Allen Medical will inspect, repair or replace all units as necessary at no cost to you. Please take steps to retrieve the units from your customers and return them to Allen Medical via the standard Return Material Authorization (RMA) process. In order to minimize this inconvenience, we will repair the Arthrex S3 Arm Sleeve Connector and return the device to you as soon as possible. For further questions, please call (978) 266-4280.
Details
- Recall number
- Z-0928-2017
- Initiated
- November 23, 2016
- Terminated
- August 20, 2019
- Product code
- HST – Apparatus, Traction, Non-Powered
- Quantity
- 420 devices
- Distribution
- US Distribution to the state of : FL
- Recalling firm
- Allen Medical Systems, Inc., Acton, MA