FDANovember 21, 2016device
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...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Endotoxin values from testing of retains slightly exceeded the established specification.
What to do
FDA enforcement status: Terminated
Brands named
tepha
Recall history
No related federal recalls on record for this brand yet.
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