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restor3d Utility Wedge
Restor3d, Inc. · Model 1105-2723120505R · UDI-DI 00840097503554
1
510(k) clearances
23
Adverse events
9
Recalls
38
Facilities
Description
Titanium (Ti-6Al-4V) Subtalar Wedge, Right Foot, Large Footprint, 12mm Thickness, 5 Degree
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-10 | Paragon 28, Inc. | Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility. |
| 2026-07-10 | Paragon 28, Inc. | Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility. |
| 2018-09-28 | Paragon 28, Inc. | It has been determined that the wedge implant kit is permanently mislabeled with the wrong size. The wedge implant is a 10mm size and is permanently marked as a 12mm size. Use of t |
| 2016-04-22 | Arthrex, Inc. | Potential for polystyrene particulate presence. |
| 2016-04-22 | Arthrex, Inc. | Potential for polystyrene particulate presence. |
| 2016-04-22 | Arthrex, Inc. | Potential for polystyrene particulate presence. |
| 2016-04-22 | Arthrex, Inc. | Potential for polystyrene particulate presence. |
| 2016-04-22 | Arthrex, Inc. | Potential for polystyrene particulate presence. |
| 2016-04-22 | Arthrex, Inc. | Potential for polystyrene particulate presence. |
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Get your free API keyRead the docsData 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.