Home › Device types › GFJ
Mallet, Surgical, General & Plastic Surgery
FDA product code GFJ · Class 1 · General, Plastic Surgery
764
Registered devices
17
Adverse events
2
Recalls
3
510(k) clearances
Devices with this code
Sklar® — SKLAR CORPORATIONPower Dental U.S.A., Inc. — Power Dental U.S.A. Inc.KMEDIC — TELEFLEX INCORPORATEDGen2 — SURGIX MEDICAL LLCNA — DEPUY ORTHOPAEDICS, INC.MILLENNIUM — Avalign Technologies, Inc.Symmetry Heath — ASPEN SURGICAL PRODUCTS, INC.Ambler Surgical — AMBLER SURGICAL CORP.Life Instruments — Life Instrument CorporationV. Mueller — STERIS CORPORATIONAmbler Surgical — AMBLER SURGICAL CORP.Van Sickle — VAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDRZ Medizintechnik GmbH — RZ-Medizintechnik GmbHSurtex — SURTEX INSTRUMENTS LTD.Novo Surgical Inc. — NOVO SURGICAL, INC.KMEDIC — TELEFLEX INCORPORATEDAvalign — Avalign Technologies, Inc.Ambler Surgical — AMBLER SURGICAL CORP.ORTHOMED — ORTHO-MED, INC.Surtex — SURTEX INSTRUMENTS LTD.HAMMER — KLS-Martin L.P.BOSS Instruments — BOSS INSTRUMENTS, LTD., INC.Sklar® — SKLAR CORPORATIONSurtex — SURTEX INSTRUMENTS LTD.
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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