Home › Device types › OIY
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
FDA product code OIY · Class 2 · Orthopedic
0
Registered devices
1,436
Adverse events
6
Recalls
12
510(k) clearances
Devices with this code
Klassic Femoral Augment, Distal — TOTAL JOINT ORTHOPEDICS, INC.Optimotion Blue CR HCCR Total Knee System — OPTIMOTION IMPLANTS LLCVANGUARD KNEE SYSTEM — Biomet Orthopedics, LLCPERSONA® Vivacit-E® — Zimmer, Inc.Genflex2 Total Knee System — GLOBUS MEDICAL, INC.TriVerse Meniscal Insert CR — SIGNATURE ORTHOPAEDICS PTY LTDPersona® Vivacit-E® — Zimmer, Inc.Vanguard® Knee System — Biomet Orthopedics, LLCKlassic Femoral Augment, Posterior — TOTAL JOINT ORTHOPEDICS, INC.Vanguard® Knee System — Biomet Orthopedics, LLCVanguard XP® Instrumentation — Biomet Orthopedics, LLCPersona® The Personalized Knee System — Zimmer, Inc.Persona® — Zimmer, Inc.Genflex2 Total Knee System — GLOBUS MEDICAL, INC.Truliant, Activit-E — Exactech, Inc.PERSONA™ Vivacit-E® — Zimmer, Inc.iTotal Identity CR — Conformis, Inc.BKS E-Vitalize — Ortho Development CorporationPersona® Vivacit-E® — Zimmer, Inc.GENflex2 Total Knee System — GLOBUS MEDICAL, INC.Truliant, Activit-E — Exactech, Inc.Persona® — Zimmer, Inc.Vanguard® Vivacit-E® — Zimmer, Inc.Signature — Materialise NV
Recent 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 gam |
| 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 |
| 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 |
| 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 i |
| 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 |
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