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Terminated

LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.

FDA Recall Z-1406-2022 · Posted None

Recalling FirmAesculap Implant Systems LLC
Recall StatusTerminated
Product CodeHXW
Date Initiated2021-06-30
Date Terminated2024-04-17
Product Quantity2 pieces

Reason for Recall

Customized coronal rod benders may deform the implant when used with the spinal system devices.

Firm 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.

Root Cause

Device Design

Distribution Pattern

United States: CO

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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