Home › Device types › KRO
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
FDA product code KRO · Class 2 · Orthopedic
0
Registered devices
9,492
Adverse events
124
Recalls
87
510(k) clearances
Devices with this code
LEGION — Smith & Nephew, Inc.USTAR II Knee System — UNITED ORTHOPEDIC CORP.LINK Endo-Model EVO Knee System — WALDEMAR LINK GmbH & Co. KGLINK Endo-Model EVO Knee System — WALDEMAR LINK GmbH & Co. KGOSS™ Orthopedic Salvage System — Biomet Orthopedics, LLCEndo-Model SL Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KGLEGION — Smith & Nephew, Inc.Orthopedic Salvage System (OSS) — Biomet Orthopedics, LLCTriathlon — Howmedica Osteonics Corp."UNITED" USTAR II Knee System — UNITED ORTHOPEDIC CORP.OSS™ Orthopedic Salvage System — Biomet Orthopedics, LLCLEGION — Smith & Nephew, Inc.OSS™ Orthopedic Salvage System / Arcos® — Biomet Orthopedics, LLC"UNITED" USTAR II Hip System — UNITED ORTHOPEDIC CORP.Triathlon — Howmedica Osteonics Corp.LinkSymphoKnee — WALDEMAR LINK GmbH & Co. KGFINN KNEE SYSTEM — Biomet Orthopedics, LLCOSS™ Orthopedic Salvage System — Biomet Orthopedics, LLCORTHOPEDIC SALVAGE SYSTEM (OSS) — Biomet Orthopedics, LLCCompress® Device — Biomet Orthopedics, LLCOSS STRAIGHT STEM TRIAL — Biomet Orthopedics, LLCLINK Endo-Model EVO Knee System — WALDEMAR LINK GmbH & Co. KGLINK Endo-Model EVO Knee System — WALDEMAR LINK GmbH & Co. KGNexGen® — Zimmer, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-30 | Howmedica Osteonics Corp. | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential f |
| 2026-07-06 | Waldemar Link GmbH & Co. KG (Mfg Site) | The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a pro |
| 2026-05-20 | United Orthopedic Corp. | Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. |
| 2026-05-19 | DEPUY (IRELAND) | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
| 2026-05-19 | DEPUY (IRELAND) | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
| 2026-04-03 | DEPUY (IRELAND) | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
| 2026-04-03 | DEPUY (IRELAND) | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
| 2026-04-03 | DEPUY (IRELAND) | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
| 2026-04-03 | DEPUY (IRELAND) | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
| 2026-04-03 | DEPUY (IRELAND) | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
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