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Arthrex®

ARTHREX, INC. · Model AR-9341-18T · UDI-DI 00888867287167

PKCQHQ Prescription
10
510(k) clearances
363
Adverse events
3
Recalls
77
Facilities

Description

ECLIPSE TI HUMERAL HEAD, SIZE 41/18

Recalls

DateFirmReason
2024-08-29Tornier, IncOne lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).
2019-10-10Zimmer Biomet, Inc.Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
2019-08-21Zimmer GmbHIncorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14.

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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.