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restor3d Kinos Axiom PSR
Restor3d, Inc. · Model 5831-9006 · UDI-DI 00840097509945
OYK
Prescription
1
510(k) clearances
11
Adverse events
2
Recalls
12
Facilities
Description
Axiom coupled PSR, Flat-cut
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-27 | restor3d Inc. | Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrumentation, reduced fix |
| 2011-11-17 | Integra LifeSciences Corp. | During 6/30/2010 to 8/17/2011 the firm received five (5) incident complaints of breakage of the threaded part of the compression guide which potentially occurred when: 1) a compre |
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