FDAMay 22, 2017device
Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use. ech 1.5" N...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to perform calcar planing to the bone, i.e., to include a caution statement about the potential for instrument breakage if bending or torsional forces are applied.
What to do
FDA enforcement status: Terminated
Brands named
exactech
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABrand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X2026-02-03
- FDABrand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-052026-02-03
- FDABrand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Component: Not a component2025-09-05
- FDABrand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Component: Not a component2025-09-05
- FDABrand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: Not a component2025-09-05
- FDAExactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/ 320-42-03,145-DEG PE 42MM HUM LINER +2.5/2025-08-15
- FDAExactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM LINER +0), REF: 322-42-03 (145-DEG PE 42MM HUM LINER +2.5)2025-08-15
- FDANovation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51 NV EHXL NTRL LNR G132MM 140-32-52 NV EHXL NTRL LNR G232MM 140-32-53 NV EHXL NTRL LNR G332MM 140-32-54 ...2024-12-31
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