LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.
- Company
- Aesculap Implant Systems Llc
- Recall Initiated
- June 30, 2021
- Terminated
- April 17, 2024
- Recall Number
- Z-1406-2022
- Quantity
- 2 pieces
- Firm Location
- Center Valley, PA
Reason for Recall
Customized coronal rod benders may deform the implant when used with the spinal system devices.
Distribution
United States: CO
Lot / Code Info
LOT: 2930901A
Root Cause
Device Design
Action Taken
A recall notification titled "Medical Device Market Withdrawal Notification" was emailed June 30, 2021. The letter identifies the affected product as Customized Coronal Rod Benders TEK 1939 and TEK 1940 and requests the customer to 1) Identify affected inventory, 2) Discontinue use, 3) Submit the acknowledgement form and 4) Contact AIS Customer Service to arrange for return of affected product at (866) 229-3002.
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