Tepha Incorporated recalls GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use as a bioresorbable scaffold fo…

Recall date

November 21, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0948-2017

FDA classification

Class II

Brand / firm

Tepha Incorporated

Sold / distributed

Nationwide Distribution to IN, CA, FL, MI, NV, and MT

Why it was recalled

Endotoxin values from testing of retains slightly exceeded the established specification.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction. GalaSHAPE" 3D is also indicated for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.