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USA Series

Gyrus ACMI, LLC · Model G27L-12A · UDI-DI 00821925008915

HEW Prescription
1
510(k) clearances
254
Adverse events
4
Recalls
21
Facilities

Description

USA Series Long Autoclavable Operative Telescope 12 Degrees, 2.7 mm Diameter

Recalls

DateFirmReason
2021-04-23CooperSurgical, Inc.The affected Koh Cup were incorrectly packaged with a 3.5cm Ultem Koh cup, P/N 34131-04, instead of a 3.0cm Ultem Koh cup, P/N 34131-03 as required.
2019-06-14CooperSurgical, Inc.The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, leading to serious health cons
2019-06-14CooperSurgical, Inc.The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, leading to serious health cons
2018-09-04CooperSurgical, Inc.The seal of the sterile pouch may be compromised, thereby increasing the risk of infection.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.