Z-1198-2017Class II

Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01

Name: Z-1198-2017 Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01
Creator: Allen Medical Systems, Inc.
Published: 2017-01-03
License: https://open.fda.gov/license/

Allen Medical Systems, Inc. / initiated 2017-01-03 / Terminated / root cause: design

FDA source

Allen Medical Systems, Inc. began a recall of Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01 Product Usage: The Arthrex Lateral Decubitus Shoulder Positioner is intended to allow for the... on 2017-01-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1198-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-03
Posted: 2017-02-14
Terminated: 2018-10-03
Recalling firm: Allen Medical Systems, Inc.
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.
Product code: HST Apparatus, Traction, Non-Powered
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.
Root cause tag: design
FDA root cause: Device Design
Action: The distributor was notified of the recall via email on January 3, 2017. The letter identified the affected product, problem and actions to be taken. The letter instructs the consignee to remove the product from service and follow instructions to return the device to Allen Medical for repair.
Quantity in commerce: 112 devices
Distribution: US state of FL
Product codes and lots: 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, 501823, 501824, 501825, 501826, 501827, 501828, 501829, 501830, 501831, 501832, 501833, 501834, 501835, 501836, 501837, 501838, 501839, 501840, 501841, 501842, 501848, 501849, 501850, 501851, 501852, 501853, 501854, 501855, 501856, 501857, 501863, 501864, 501865, 501866, 501867, 501868, 501869, 501870, 501871, 501872, 501878, 501879, 501880, 501881, 501882, 501883, 501884, 501885, 501886, 501887, 501888, 501889, 501890, 501891, 501892, 501893, 501894, 501895, 501896, 501897, 510733, 510734, 510735, 510736, 510737, 510738, 510739, 510740, 510741, 510742, 510743, 510744, 510745, 510746, 510747, 510748, 510749, 510750, 510751, 510752, 510834, 510835, 510836, 510837, 510838, 510839, 510840

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1198-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1198-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-22	2017-02-14

Product code HST

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)