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Osteotec Silicone Finger Implant - Size 9

OSTEOTEC LIMITED · Model OSTF-9 · UDI-DI 05060183090101

KYJ Prescription

510(k) clearances

494

Adverse events

Recalls

Facilities

Description

The Osteotec Silicone Finger Implant (uncemented) is a one-piece, flexible silicone elastomer implant which is placed in the proximal and distal intramedullary canals of either metacarpophalangeal (MCP) or proximal interphalangeal (PIP) finger joints during resection arthroplasty.

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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.