Prosthesis, Finger, Constrained, Polymer
FDA adverse event reports and recall history for prosthesis, finger, constrained, polymer (product code KYJ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 485
- Deaths
- 0
- Injuries
- 392
- Malfunctions
- 54
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-07-31Open, ClassifiedProcess change control
Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5) Software Version: N/A Product Description: The Osteotec Silicone Finger Implant is a one-piece, sterile, flexible silicone elastomer implant which is placed, during arthroplasty, in the proximal and distal intramedullary canals of either metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joints. The implant is not fixed into the bones and becomes stabilized by the encapsulation process. The implant is available in eleven sizes to meet various anatomical variations and is supplied sterile. Component: N/A
There is the potential that the silicone implant may contain foreign material
- TerminatedProcess control
SWANSON FINGER JOINT #1, Part Number 4700001
The firm discovered a lack of adequate documentation confirming sterility on certain products.
- TerminatedProcess control
SWANSON FINGER JOINT #2, Part Number 4700002
The firm discovered a lack of adequate documentation confirming sterility on certain products.
- TerminatedLabeling mix-ups
Ascension Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage: The Ascension Silicone PIP implant is intended for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis.
Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant
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