Aesculap Implant Systems LLC recalls AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a su…
- Recall date
- September 25, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1383-2022
- FDA classification
- Class II
- Brand / firm
- Aesculap Implant Systems LLC
- Sold / distributed
- United States: TX and AK
Why it was recalled
Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle
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