Aesculap Implant Systems LLC LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.
Brand
Aesculap Implant Systems LLC
Lot Codes / Batch Numbers
LOT: 2930901A
Products Sold
LOT: 2930901A
Aesculap Implant Systems LLC is recalling LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery. due to Customized coronal rod benders may deform the implant when used with the spinal system devices.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Customized coronal rod benders may deform the implant when used with the spinal system devices.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026