Recall Z-0691-2020— Integra Lifesciences Sales Llc

Name: FDA recall Z-0691-2020
Creator: U.S. Food and Drug Administration
Published: 2019-11-04

Class II · Terminated

Class II FDA medical device recall by Integra Lifesciences Sales Llc, initiated 2019-11-04, terminated 2020-05-05. It names one FDA 510(k) clearance: K082231. Product: 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.. Reason: Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant.

Recalling firm: Integra Lifesciences Sales Llc
Classification: Class II
Status: Terminated
Initiated: 2019-11-04
Terminated: 2020-05-05
Firm location: Plainsboro, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K082231 — ASCENSION SILICONE PIPAscension Orthopedics, Inc.·cleared 2009-01-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant

Data sourced from openFDA. This site is unofficial and independent of the FDA.