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Surtex

SURTEX INSTRUMENTS LTD. · Model OR-480-18 · UDI-DI 05055445941291

GFJ
3
510(k) clearances
17
Adverse events
2
Recalls
176
Facilities

Description

Partsch Mallet With Hollow Handle 19 cm - 7 1/2" Head Ø 22.0 mm - Weight 200 Grams Stainless Steel

Recalls

DateFirmReason
2019-11-11Smith & Nephew, Inc.There is a a potential failure mode associated with the use of the mallet, wherein the poly tip of the mallet may become loose and/or come off during use. If the potential failure
2017-02-20Signal Medical CorporationPotential for poly tip of the mallet to come off during use. Potential for foreign material in the surgical field or delay in surgery. Reminder for customers that the poly tip mus

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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.