Home › Device types › HRY
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
FDA product code HRY · Class 2 · Orthopedic
12,761
Registered devices
9,644
Adverse events
68
Recalls
91
510(k) clearances
Devices with this code
Legion — Smith & Nephew, Inc.Uniglide Unicondylar Knee Prosthesis — CORIN LTDINSTRUMENT — Howmedica Osteonics Corp.Implant Partners — Microport Orthopedics Inc.Vanguard® SSK Knee System — Biomet Orthopedics, LLCVanguard Knee System — Biomet Orthopedics, LLCLinkSymphoKnee — WALDEMAR LINK GmbH & Co. KGJourney II — Smith & Nephew, Inc.JII — Smith & Nephew, Inc.Legion — Smith & Nephew, Inc.Legion — Smith & Nephew, Inc.Implant Partners — Microport Orthopedics Inc.JOURNEY — Smith & Nephew, Inc.NA — Smith & Nephew, Inc.LEGION — Smith & Nephew, Inc.LinkSymphoKnee — WALDEMAR LINK GmbH & Co. KGAGC Tradition Knee System — Biomet Orthopedics, LLCMaxim Knee System — Biomet Orthopedics, LLCJourney II — Smith & Nephew, Inc.Legion — Smith & Nephew, Inc.Implant Partners — Microport Orthopedics Inc.INSTRUMENT — Howmedica Osteonics Corp.Anthology — Smith & Nephew, Inc.Unix — Howmedica Osteonics Corp.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-05-03 | MicroPort Orthopedics Inc. | One confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP Non-Porous Femoral Right was opened during surgery and contain |
| 2022-12-15 | Biomet, Inc. | Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required outer carton, which forces the Tyvex pouch to be fold |
| 2022-10-28 | MicroPort Orthopedics Inc. | One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 191671 |
| 2022-10-28 | MicroPort Orthopedics Inc. | One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 191671 |
| 2021-08-30 | Exactech, Inc. | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. |
| 2021-03-19 | Aesculap Implant Systems LLC | Malfunction- loosening of the implant resulting in a potential revision surgery |
| 2021-03-19 | Aesculap Implant Systems LLC | Malfunction- loosening of the implant resulting in a potential revision surgery |
| 2021-03-19 | Aesculap Implant Systems LLC | Malfunction- loosening of the implant resulting in a potential revision surgery |
| 2021-03-19 | Aesculap Implant Systems LLC | Malfunction- loosening of the implant resulting in a potential revision surgery |
| 2021-03-19 | Aesculap Implant Systems LLC | Malfunction- loosening of the implant resulting in a potential revision surgery |
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