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Healix

NVision Biomedical Technologies, Inc. · Model CSRW-1000T-240 · UDI-DI 00810005666459

HWW Prescription
0
510(k) clearances
15
Adverse events
17
Recalls
113
Facilities

Description

2.0 - 2.5 Countersink. 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

DateFirmReason
2019-04-08Zimmer GmbHAn investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
2019-04-08Zimmer GmbHAn investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
2019-04-08Zimmer GmbHAn investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
2019-04-08Zimmer GmbHAn investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
2019-04-08Zimmer GmbHAn investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
2019-04-08Zimmer GmbHAn investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
2019-04-08Zimmer GmbHAn investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
2019-04-08Zimmer GmbHAn investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
2019-04-08Zimmer GmbHAn investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
2019-04-08Zimmer GmbHAn investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

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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.