Data Foundry

Medical device recalls 2022

LEFT CORONAL BENDER — Class II medical device recall Z-1406-2022

Terminated recall by Aesculap Implant Systems LLC, reported 2022-07-27. Customized coronal rod benders may deform the implant when used with the spinal system devices.

Recall numberZ-1406-2022
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmAesculap Implant Systems LLC, Center Valley, PA, United States
Recall initiated2021-06-30
Classified2022-07-19
Reported by FDA2022-07-27
Terminated2024-04-17
Quantity2 units
Lot numbers2930901A

Product

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1406-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.