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Tepha Incorporated recalls GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use as a bioresorbable scaffold fo
Recalled January 11, 2017 · FDA recall Z-0948-2017 · Tepha Incorporated
Hazard
Endotoxin values from testing of retains slightly exceeded the established specification. · FDA Class II
Units
29
Sold at
Nationwide Distribution to IN, CA, FL, MI, NV, and MT
Description
Endotoxin values from testing of retains slightly exceeded the established specification.
Product
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.
Manufacturer(s)
Tepha Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →