FDA Device recall Z-0948-2017
GalaSHAPE 3D
- FDA Device
- Class II
- terminated
- Published 2017-01-11
On 2017-01-11 the FDA classified a Class II recall of GalaSHAPE 3D by Tepha, citing endotoxin values from testing of retains slightly exceeded the established specification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0948-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-21 |
| Published | 2017-01-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Tepha |
| Distribution | US |
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.
Reason
Endotoxin values from testing of retains slightly exceeded the established specification.
Identifiers
| code_info | Lot Number: 160294 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0948-2017%22
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