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.
Enforcement
- Recall Number
- Z-0948-2017
- Event ID
- 75827
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Tepha Incorporated
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- January 11, 2017
- Initiation Date
- November 21, 2016
- Classification Date
- January 5, 2017
- Termination Date
- January 5, 2017
- Address
- 99 Hayden Ave Ste 360, N/A, Lexington, MA, 02421-7966, United States
Description
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.
Endotoxin values from testing of retains slightly exceeded the established specification.
Lot Number: 160294
Nationwide Distribution to IN, CA, FL, MI, NV, and MT
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