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Integra® First Choice®
Ascension Orthopedics, Inc. · Model TRL600MED · UDI-DI 10381780236757
KXE
Prescription
1
510(k) clearances
45
Adverse events
3
Recalls
18
Facilities
Description
The Modular Ulnar Head Collar trial attaches to a trial stem to adapt for a medium or long osteotomy and simulate actual implant stem.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-06-24 | Stryker Howmedica Osteonics Corp. | Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromise |
| 2015-06-24 | Stryker Howmedica Osteonics Corp. | Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromise |
| 2011-12-03 | Ascension Orthopedics, Inc | A recent review conducted by Ascension Orthopedics revealed that certain modifications were made to the First Choice System and should have been preceded by a submission of a filin |
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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.