Home / Recalls / Allen Medical Systems, Inc. / Z-1198-2017

Z-1198-2017 Class II Terminated

Recalled by Allen Medical Systems, Inc. — Acton, MA

FDA device recall Z-1198-2017 was initiated by Allen Medical Systems, Inc. on January 3, 2017 and is designated Class II. 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. The recall status is terminated (terminated October 3, 2018). Affected quantity: 112 devices.

Recall Details

Product Type
Devices
Report Date
February 22, 2017
Initiation Date
January 3, 2017
Termination Date
October 3, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
112 devices

Product Description

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.

Distribution Pattern

US state of FL

Code Information

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

Other recalls by Allen Medical Systems, Inc.

  • Z-1262-2018 Class II — F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table acc (February 21, 2018)
  • Z-0642-2018 Class II — Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position pa (October 6, 2017)
  • Z-0641-2018 Class II — Allen Medical Bow Frame Model A-70800. Surgical platform used to position patie (October 6, 2017)
  • Z-0928-2017 Class II — Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and dist (November 23, 2016)
  • Z-0959-2013 Class II — Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture T (February 28, 2013)

FDA data resources