Class II — Tepha Incorporated
| Recalling firm | Tepha Inc. |
|---|---|
| Registered facility | Tepha, Incorporated (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Endotoxin values from testing of retains slightly exceeded the established specification. |
| 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. |
| Quantity | 29 |
| Distribution | Nationwide Distribution to IN, CA, FL, MI, NV, and MT |
| Initiated | 2016-11-21 |
| Classified | 2017-01-05 |
| Terminated | 2017-01-05 |
| Recall number | Z-0948-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Tepha Incorporated (Z-0948-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75827/
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