Recall Z-1406-2022— Aesculap Implant Systems LLC
Class II · Terminated
Class II FDA medical device recall by Aesculap Implant Systems LLC, initiated 2021-06-30, terminated 2024-04-17. FDA's recall record names no specific 510(k) clearance for this event. Product: LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.. Reason: Customized coronal rod benders may deform the implant when used with the spinal system devices..
- Recalling firm
- Aesculap Implant Systems LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-06-30
- Terminated
- 2024-04-17
- Firm location
- Center Valley, PA, United States
Product description
LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.
Reason for recall
Customized coronal rod benders may deform the implant when used with the spinal system devices.
Data sourced from openFDA. This site is unofficial and independent of the FDA.