Home › Device types › HWA
Impactor
FDA product code HWA · Class 1 · Orthopedic
3,022
Registered devices
19,608
Adverse events
27
Recalls
4
510(k) clearances
Devices with this code
Movement Great Toe System — Smith & Nephew, Inc.Integra® Jarit® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONTRIGEN MAX — Smith & Nephew, Inc.Intramedullary Plugs — WALDEMAR LINK GmbH & Co. KGDJO SURGICAL — Encore Medical, L.P.Trigen — Smith & Nephew, Inc.DJO SURGICAL — Encore Medical, L.P.na — MEDTRONIC SOFAMOR DANEK, INC.APEX Knee System — Omni Life Science, Inc.Humelock II Cemented Shoulder System — FX SOLUTIONSMAESTRO(TM) TOTAL WRIST — Biomet Orthopedics, LLCATTUNE — DEPUY (IRELAND)CONSERVE® — Microport Orthopedics Inc.KMEDIC — TELEFLEX INCORPORATEDVERSA DIAL(TM) SHOULDER SYSTEM — Biomet Orthopedics, LLCEVOLUTION® — Microport Orthopedics Inc.U-Motion II — UNITED ORTHOPEDIC CORP.iNSitu™ Hip System — NEXTSTEP ARTHROPEDIX, LLCVG2 — Medos International SàrlInnomed, Inc. — INNOMED, INC.V. Mueller — STERIS CORPORATIONPLATE IMPACTOR — Biomet Orthopedics, LLCAPEX Knee System — Omni Life Science, Inc.U-Motion™ — UNITED ORTHOPEDIC CORP.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-03 | Exactech, Inc. | Impactor handle may be missing cross-pin |
| 2026-02-03 | Exactech, Inc. | Impactor handle may be missing cross-pin |
| 2024-10-30 | INCIPIO DEVICES | Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld. |
| 2023-06-05 | Exactech, Inc. | The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction. |
| 2020-05-12 | XTANT Medical | The strike plate fractured off from the forceps inserter devices with minimal impaction or force due to unsatisfactory weld. |
| 2019-08-16 | Enztec Limited | The femoral impactors have a higher than normal risk of the arm breaking. During impaction the tip of the arm may fracture and separate from the instrument. Th |
| 2019-07-24 | Exactech, Inc. | The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media. |
| 2017-08-28 | Zimmer Biomet, Inc. | Potential for the Persona Partial Knee Impactor Pad to fracture. |
| 2017-02-09 | Encore Medical, Lp | During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the |
| 2017-02-09 | Encore Medical, Lp | During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the |
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