Z-1406-2022Class II

LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery

Name: Z-1406-2022 LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery
Creator: Aesculap Implant Systems LLC
Published: 2021-06-30
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2021-06-30 / Terminated / root cause: design

FDA source

Aesculap Implant Systems LLC began a recall of LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery on 2021-06-30. FDA classified it as Class II and gives the reason as "Customized coronal rod benders may deform the implant when used with the spinal system devices". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1406-2022
Classification: Class II
Status: Terminated
Initiated: 2021-06-30
Posted: 2022-07-19
Terminated: 2024-04-17
Recalling firm: Aesculap Inc
Product: LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.
Product code: HXW Bender
Reason for recall: Customized coronal rod benders may deform the implant when used with the spinal system devices.
Root cause tag: design
FDA 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 in commerce: 2 pieces
Distribution: United States: CO
Product codes and lots: LOT: 2930901A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1406-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1405-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-27	2022-07-19
Z-1406-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-27	2022-07-19

Product code HXW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)