Aesculap Implant Systems LLC recalls RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.
- Recall date
- June 30, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1405-2022
- FDA classification
- Class II
- Brand / firm
- Aesculap Implant Systems LLC
- Sold / distributed
- United States: CO
Why it was recalled
Customized coronal rod benders may deform the implant when used with the spinal system devices.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.
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