Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01 Product Usage: The Arthrex Lateral Decubitus Shoulder Posi
FDA device recall Z-1198-2017 · posted 2017-02-14 · Terminated
Recall details
- Recalling firm
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HST
- Quantity affected
- 112 devices
- Distribution
- US state of FL
- Date initiated
- 2017-01-03
- Date posted
- 2017-02-14
- Date terminated
- 2018-10-03
- Location
- Acton, MA
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