restor3d

Summary

restor3d’s selected commercial implant families have multiple 510(k) decisions, including current Kinos, TIDAL, shoulder and personalized-knee records. The acquired Conformis history is now included, with original applicants preserved. Older Conformis models are not automatically current restor3d products. ^{[139][137][8][15][141][132][1]}

The matched FDA history contains 25 distinct recall events: 6 open, 18 terminated, and 1 with another/undetermined closure status. 8 were initiated during the five years beginning October 20, 2021; older open events are also retained. Z-3178-2026 (2026-07-27; open, classified): Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrumentation, reduced fixation or poor alignment of implants, implant loosening/migration, or need for revision surgery. Z-2987-2026 (2026-06-30; open, classified): Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws. Z-1569-2025 (2025-03-25; open, classified): The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard liner. ^{[125][124][123]}