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Healix

NVision Biomedical Technologies, Inc. · Model CSRW-1000T-401 · UDI-DI 00810005662437

HTW Prescription

510(k) clearances

17,868

Adverse events (5 deaths)

114

Recalls

559

Facilities

Description

Drill 2.5. The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.

Recalls

Date	Firm	Reason
2026-02-11	Waldemar Link GmbH & Co. KG (Mfg Site)	The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps de
2026-02-11	Waldemar Link GmbH & Co. KG (Mfg Site)	The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps de
2024-01-29	Waldemar Link GmbH & Co. KG (Mfg Site)	The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of
2024-01-29	Waldemar Link GmbH & Co. KG (Mfg Site)	The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of
2021-09-01	Flower Orthopedics Corporation	Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
2021-09-01	Flower Orthopedics Corporation	Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
2021-09-01	Flower Orthopedics Corporation	Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
2021-09-01	Flower Orthopedics Corporation	Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
2021-07-30	Paragon 28, Inc.	A thin wall condition between the inner cannulation and the flutes of the drill which potentially could cause a fracture through the wall of the drill to the cannulation beneath.
2021-02-24	Arthrex, Inc.	The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.