Integra Lifesciences Sales Llc: Medical Device Recall in 2019 - (Recall #: Z-0691-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 4, 2019

Date Posted: December 25, 2019

Recall Number: Z-0691-2020

Event ID: 84320

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

Status: Terminated

Product Quantity: 9 units

Code Information:

Lot Number: Lot 192715T

Distribution Pattern:

US Nationwide distribution in the state of CA.

Voluntary or Mandated:

Voluntary: Firm initiated