Recall Z-1198-2017— Allen Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Allen Medical Systems, Inc., initiated 2017-01-03, terminated 2018-10-03. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Allen Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-01-03
- Terminated
- 2018-10-03
- Firm location
- Acton, MA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.