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TORS

RADLEY SCIENTIFIC LIMITED · Model Series 1 · UDI-DI 05060634772020

JDX Prescription
10
510(k) clearances
175
Adverse events
2
Recalls
36
Facilities

Description

FAP4N2 – Cement 200mm Ø4mm Fine Access Piercer Probe (Single-use – Non-sterile)

Recalls

DateFirmReason
2019-06-04Zimmer Biomet, Inc.The products do not have sufficient data to support the labeled shelf life of 10 years.
2019-06-04Zimmer Biomet, Inc.The products do not have sufficient data to support the labeled shelf life of 10 years.

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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.