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Ascension®

Ascension Orthopedics, Inc. · Model SILMCPINSTP · UDI-DI 10381780237464

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510(k) clearances

494

Adverse events

Recalls

Facilities

Description

The Ascension Silicone MCP is intended for replacement of the metacarpophalangeal (MCP) joint where disabled by rheumatoid, degenerative, or traumatic arthritis. This set includes five silicone MCP trials to evaluate the size and fit of the implants.

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.