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U.S. Department of Health and Human Services

Class 2 Device Recall Arthrex Shoulder Suspension Tower

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  Class 2 Device Recall Arthrex Shoulder Suspension Tower see related information
Date Initiated by Firm January 03, 2017
Date Posted February 14, 2017
Recall Status1 Terminated 3 on October 03, 2018
Recall Number Z-1198-2017
Recall Event ID 76257
Product Classification Apparatus, traction, non-powered - Product Code HST
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.
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
Recalling Firm/
Manufacturer		 Allen Medical Systems, Inc.
One Post Office Square
Acton MA 01720
For Additional Information Contact Scott Wright
978-266-4280
Manufacturer 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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