Home › Device types › OIY
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
FDA product code OIY · Class 2 · Orthopedic
14,820
Registered devices
1,423
Adverse events
6
Recalls
12
510(k) clearances
Devices with this code
ITOTAL OVAL PATELLA TRIAL 35MM — Conformis, Inc.Vanguard® SSK Knee System — Biomet Orthopedics, LLCVanguard Knee System — Biomet Orthopedics, LLCPERSONA™ Trabecular Metal™ — Zimmer, Inc.BKS E-Vitalize — Ortho Development CorporationATTUNE — DEPUY (IRELAND)Vanguard® — Biomet Orthopedics, LLCVanguard® Complete Knee System — Biomet Orthopedics, LLCVanguard® Complete Knee System — Biomet Orthopedics, LLCMOBIO™ Total Knee System — B-ONE ORTHO, CORP.Persona® The Personalized Knee® System — Zimmer, Inc.Identity Imprint Knee Replacement System — Conformis, Inc.AGC Tradition Knee System — Biomet Orthopedics, LLCMaxim Knee System — Biomet Orthopedics, LLCKlassic Tibial Insert, PS-Post, Std Poly — TOTAL JOINT ORTHOPEDICS, INC.BKS E-Vitalize — Ortho Development CorporationVANGUARD CR UNIVERSAL PROVISIONAL — Biomet Orthopedics, LLCU2™ Knee — UNITED ORTHOPEDIC CORP.iTotal Identity CR — Conformis, Inc.U2™ Knee — UNITED ORTHOPEDIC CORP.IDENTITY IMPRINT — Conformis, Inc.Vanguard Complete Knee System — Biomet Orthopedics, LLCKyocera Medical Technologies, Inc. — KYOCERA MEDICAL TECHNOLOGIES, INC.Kyocera Medical Technologies, Inc. — KYOCERA MEDICAL TECHNOLOGIES, INC.
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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