Home › Device types › KYJ
Prosthesis, Finger, Constrained, Polymer
FDA product code KYJ · Class 2 · Orthopedic
176
Registered devices
499
Adverse events
4
Recalls
14
510(k) clearances
Devices with this code
Osteotec Silicone Finger Implant - Size 3 — OSTEOTEC LIMITEDIntegra® — Ascension Orthopedics, Inc.Ascension MCP Joint Replacement — Smith & Nephew, Inc.SILICONE PIP — Stryker GmbHSILICONE MCPX — Stryker GmbHAscension® — Ascension Orthopedics, Inc.NEUFLEX — DEPUY ORTHOPAEDICS, INC.Integra® — Ascension Orthopedics, Inc.Osteotec Silicone Finger Implant - Size 8 — OSTEOTEC LIMITEDSilicone PIP — Smith & Nephew, Inc.SILICONE PIP — Stryker GmbHIntegra® — Ascension Orthopedics, Inc.Ascension® — Ascension Orthopedics, Inc.Silicone PIP — Smith & Nephew, Inc.NA — Stryker GmbHNA — Stryker GmbHOsteotec Silicone Finger Implant - Size 9 — OSTEOTEC LIMITEDDIGITALIS Spacer — BRM EXTREMITIES SRLIntegra® — Ascension Orthopedics, Inc.Integra® — Ascension Orthopedics, Inc.NA — Stryker GmbHSILICONE MCP — Stryker GmbHSILICONE MCP — Stryker GmbHAscension® — Ascension Orthopedics, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-06-18 | Osteotec Limited | There is the potential that the silicone implant may contain foreign material |
| 2019-11-04 | Integra Lifesciences Sales Llc | Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant |
| 2016-11-08 | Wright Medical Technology, Inc. | The firm discovered a lack of adequate documentation confirming sterility on certain products. |
| 2016-11-08 | Wright Medical Technology, Inc. | The firm discovered a lack of adequate documentation confirming sterility on certain products. |
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