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RESTORIS ESYNTIAL
MAKO SURGICAL CORP. · Model 180743-2 · UDI-DI 00848486015343
1
510(k) clearances
1,423
Adverse events
6
Recalls
142
Facilities
Description
MCK Onlay Tibial Insert
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-02-15 | DePuy Orthopaedics, Inc. | The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of thes |
| 2022-11-14 | Conformis, Inc. | Loctite thread locker (epoxy) may not have been applied to the screw that is part of the handle. In the absence of epoxy, the screw may loosen and fall into the patient during a pr |
| 2015-09-16 | Encore Medical, Lp | The labeling is missing the size/diameter information. |
| 2014-12-11 | Zimmer, Inc. | Potential for delay in surgery and/or ball bearings to be left in the wound. Repeated cycles of sonic cleaning can break down the ball bearing retention feature (swage) on the shim |
| 2013-04-01 | Encore Medical, Lp | U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels on two packages of e+tibial inserts. There were 8 e+ tibial inserts of the same l |
| 2012-08-09 | Encore Medical, Lp | The firm is recalling one lot of 392-09-706, 3DKnee e+ Tibial insert, 9 mm, Size 6, Right. The shelf life labeling of specific lots for a component were found to be incorrect and |
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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.