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RTS
In2Bones USA, LLC · Model M30 SE010 · UDI-DI 00817906020007
KWH
Prescription
1
510(k) clearances
149
Adverse events
2
Recalls
33
Facilities
Description
RTS Flexible 1st MPJ Implant with Grommets, Size 1
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2009-04-06 | Tornier, Inc. | Tornier, Inc. has received a report of a mislabeled product due to a product mix-up. The package label indicated that the product was a model LMP-50 however the product inside the |
| 2009-03-01 | Sgarlato Med, LLC | Products with an expiration date of August, 2009 were labeled with an expiration date of May 2013. Additionally, the outer packages were labeled with an incorrect lot number. The o |
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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.