Reported Jan 11, 2017 · Terminated
GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use as a bioresorbable scaffold…
Tepha Incorporated
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tepha Incorporated · 99 Hayden Ave Ste 360 · Lexington, MA · 02421-7966
Is this the product you have?
- 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.
- Lot codes and dates
- Lot Number160294
- Amount recalled
- 29
Where it was sold
Why it was recalled
Endotoxin values from testing of retains slightly exceeded the established specification.
This product could cause temporary or reversible health problems — stop using it.
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