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RESTORIS ESYNTIAL
MAKO SURGICAL CORP. · Model 180744-4 · UDI-DI 00848486015459
1
510(k) clearances
1,136
Adverse events
8
Recalls
65
Facilities
Description
MCK Onlay Tibial Insert
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-01-19 | Mako Surgical Corporation | Possible hinge pin disassociation from the Mako Onlay Insert Extractor. |
| 2016-01-15 | Mako Surgical Corporation | Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier. |
| 2015-08-31 | ConforMIS, Inc. | May contain small amounts of ethylene glycol residue |
| 2015-08-31 | ConforMIS, Inc. | May contain small amounts of ethylene glycol residue |
| 2015-08-31 | ConforMIS, Inc. | May contain small amounts of ethylene glycol residue |
| 2014-01-09 | Mako Surgical Corporation | The product may be mislabeled and could result in the incorrect implant being used. |
| 2011-08-17 | Stryker Howmedica Osteonics Corp. | Two National Joint Registries suggest that the EIUS Unicompartmental System is associated with a higher revision rate then the unicompartmental devices. |
| 2004-10-27 | Stryker Howmedica Osteonics Corp. | The fatigue testing of the Triathlon PS Femoral Component does not consistently meet the requirements of the finite element analysis predicted load as delineated in the 510(k) subm |
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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.