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gSource

GSOURCE LLC · Model gS 81.7153 · UDI-DI 00840314269812

HXL
3
510(k) clearances
74
Adverse events
1
Recalls
202
Facilities

Description

gSlap Hammer, 10 1/2", 700g, 5/16-18-UNC-2A Thread for Sierra Disc Prep Set

Recalls

DateFirmReason
2021-07-21Implant Resource IncPotential for mallet head to become separated from mallet handle. There is also significant deformations on striking surface that were not expected

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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.