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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Allen Medical Systems, Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
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
Distribution:
Distributed in: US, FL
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1198-2017
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