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Impactor
FDA product code HWA · Class 1 · Orthopedic
2,976
Registered devices
19,287
Adverse events
27
Recalls
4
510(k) clearances
Devices with this code
ATTUNE — DEPUY (IRELAND)INBONE — WRIGHT MEDICAL TECHNOLOGY, INC.APEX Knee System — Omni Life Science, Inc.b-ONE™ Primary Acetabular System — B-ONE ORTHO, CORP.R3 — Smith & Nephew, Inc.CONSERVE® — Microport Orthopedics Inc.Ambler Surgical — AMBLER SURGICAL CORP.PROFEMUR® — Microport Orthopedics Inc.ADVANCE® — Microport Orthopedics Inc.G7 CURVED ACETABULAR SHELL INSERTER ROUND TIP — Biomet Orthopedics, LLCAPEX Knee System — Omni Life Science, Inc.Made-To-Order — WRIGHT MEDICAL TECHNOLOGY, INC.Integra® Ruggles®-Redmond™ — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDELTA XTEND — DEPUY (IRELAND)Aequalis Reversed II — TORNIERG7 DUAL MOBILITY LINER IMPACTOR ADAPTOR — Biomet Orthopedics, LLCMSI — Modern Surgical Instruments LLCTahoe Unicompartmental Knee System — Shalby Advanced Technologies, Inc.Ambler Surgical — AMBLER SURGICAL CORP.ATTUNE — DEPUY (IRELAND)CONSERVE® — Microport Orthopedics Inc.Innomed, Inc. — INNOMED, INC.RING RETAINER — Biomet Orthopedics, LLCMSI Precision Specialty Instruments — Med Saver, Inc.
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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