Arthrex Shoulder Suspension Tower — Class II medical device recall Z-1198-2017
Terminated recall by Allen Medical Systems, Inc., reported 2017-02-22, distributed in FL. During use, there is a potential scenario which could allow the fastening screws attaching covers to come loos
| Recall number | Z-1198-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Allen Medical Systems, Inc., Acton, MA, United States |
| Recall initiated | 2017-01-03 |
| Classified | 2017-02-14 |
| Reported by FDA | 2017-02-22 |
| Terminated | 2018-10-03 |
| Distributed | FL |
| Quantity | 112 devices |
| Reason classes | sterility |
| Serial numbers | 501798, 501799, 501800, 501801, 501802, 501803, 501804, 501805, 501806, 501807, 501808, 501809, 501810, 501811, 501812, 501813, 501814, 501815, 501816, 501817, 501818, 501819, 501820, 501821, 501822 and 87 more |
| Model numbers | AR-1650-01 |
Product
Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01 Product Usage: The Arthrex Lateral Decubitus Shoulder Positioner is intended to allow for the controlled manipulation of the arm and shoulder joint during arthroscopic surgical procedures.
Reason for recall
During use, there is a potential scenario which could allow the fastening screws attaching covers to come loose and potentially land in the sterile field causing a delay in surgery.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1198-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.