Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
GalaSHAPE 3D Recalled by Tepha Incorporated Due to Endotoxin values from testing of retains slightly exceeded...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Tepha Incorporated directly.
Affected Products
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.
Quantity: 29
Why Was This Recalled?
Endotoxin values from testing of retains slightly exceeded the established specification.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Tepha Incorporated
Tepha Incorporated has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report