Device 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.
Z-0948-2017
Product summary
- Event
- Event 75827
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29
- Official record key
device-enforcement:Z-0948-2017
Official wording
Reason: Endotoxin values from testing of retains slightly exceeded the established specification.
Code information: Lot Number: 160294
Distribution pattern: Nationwide Distribution to IN, CA, FL, MI, NV, and MT
Derived failure modes
-
Unknown
Endotoxin values from testing of retains slightly exceeded the established specification.