Home › Device types › KRR
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
FDA product code KRR · Class 2 · Orthopedic
3,183
Registered devices
249
Adverse events
9
Recalls
27
510(k) clearances
Devices with this code
INSTRUMENT — Howmedica Osteonics Corp.PRELUDE PATELLO-FEMORAL SYSTEM — Biomet Orthopedics, LLCINSTRUMENT — Howmedica Osteonics Corp.Arthrex® — ARTHREX, INC.RESTORIS ESYNTIAL — MAKO SURGICAL CORP.INSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.RESTORIS ESYNTIAL — MAKO SURGICAL CORP.RESTORIS — MAKO SURGICAL CORP.Arthrex® — ARTHREX, INC.Arthrex® — ARTHREX, INC.Arthrex® — ARTHREX, INC.INSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.RESTORIS ESYNTIAL — MAKO SURGICAL CORP.RESTORIS ESYNTIAL — MAKO SURGICAL CORP.Arthrex® — ARTHREX, INC.INSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-12-22 | MEDLINE INDUSTRIES, LP - Northfield | The recall is due to observed intra-operative screw failure. When pre-drilled with 1.3mm drill bit for 2.0mm screws and 1.6mm drill bit for 2.4mm we have observ |
| 2022-12-22 | MEDLINE INDUSTRIES, LP - Northfield | The recall is due to observed intra-operative screw failure. When pre-drilled with 1.3mm drill bit for 2.0mm screws and 1.6mm drill bit for 2.4mm we have observ |
| 2022-12-22 | MEDLINE INDUSTRIES, LP - Northfield | The recall is due to observed intra-operative screw failure. When pre-drilled with 1.3mm drill bit for 2.0mm screws and 1.6mm drill bit for 2.4mm we have observ |
| 2017-11-29 | Zimmer Biomet, Inc. | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE ba |
| 2017-11-29 | Zimmer Biomet, Inc. | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE ba |
| 2016-03-09 | Biomet, Inc. | Inadequate design control. |
| 2016-01-11 | Zimmer Biomet, Inc. | LDPE bag containing the implant adheres to the highly polished implant surface. |
| 2014-07-30 | Zimmer, Inc. | Internal review found that five (5) PFJ implant forgings were identified as have forged laps during receiving inspection process for raw material. These five fo |
| 2013-08-30 | Zimmer, Inc. | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. |
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