FDA Medical Device Recalls (openFDA)
Aesculap Implant Systems LLC: LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.
- Recall number
- Z-1406-2022
- Recalling firm
- Aesculap Implant Systems LLC
- Product
- LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.
- Status
- Terminated
- Initiated
- 2021-06-30
- Posted
- not on file
- Terminated
- 2024-04-17
- Reason
- Customized coronal rod benders may deform the implant when used with the spinal system devices.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 2 pieces
- Distribution
- United States: CO
- Lot, serial or model codes
- LOT: 2930901A
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HXW
- Firm FEI
- 2916714
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28