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Integra®

Ascension Orthopedics, Inc. · Model SILPIPINSTP · UDI-DI 10381780235125

KYJ Prescription

510(k) clearances

499

Adverse events

Recalls

Facilities

Description

The Integra Silicone PIP is intended for replacement of the proximal interphalangeal (PIP) joint where disabled by rheumatoid, degenerative, or traumatic arthritis. This set includes silicone PIP trials to evaluate size and fit of the implants. Instruments are also included.

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.