Home › Device types › GFJ
Mallet, Surgical, General & Plastic Surgery
FDA product code GFJ · Class 1 · General, Plastic Surgery
724
Registered devices
17
Adverse events
2
Recalls
3
510(k) clearances
Devices with this code
BOSS Instruments — BOSS INSTRUMENTS, LTD., INC.Millennium — Avalign Technologies, Inc.MILLENNIUM — Avalign Technologies, Inc.Integra® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONMILLENNIUM — Avalign Technologies, Inc.Sklar® — SKLAR CORPORATIONAvalign — Avalign Technologies, Inc.devemed — devemed GmbHRZ Medizintechnik GmbH — RZ-Medizintechnik GmbHMALLET — KLS-Martin L.P.Adler Instrument Company — Adler, Inc.MILLENNIUM — Avalign Technologies, Inc.MILLENNIUM — Avalign Technologies, Inc.Cannulated Hammer — CURVAFIX, INC.Quinelato — Schobell Industrial LtdaPaul Banditt — Terlain Enterprises, Inc.Power Dental USA — Power Dental U.S.A. Inc.Novo Surgical — NOVO SURGICAL, INC.Ambler Surgical — AMBLER SURGICAL CORP.gSource — GSOURCE LLCSklar® — SKLAR CORPORATIONHNM MEDICAL — HNM STAINLESS, LLC.PILLING — TELEFLEX INCORPORATEDV. Mueller — STERIS CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-11-11 | Smith & 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 th |
| 2017-02-20 | Signal Medical Corporation | Potential 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 t |
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