GalaSHAPE 3D — Class II medical device recall Z-0948-2017
Terminated recall by Tepha Incorporated, reported 2017-01-11, distributed nationwide. Endotoxin values from testing of retains slightly exceeded the established specification.
| Recall number | Z-0948-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tepha Incorporated, Lexington, MA, United States |
| Recall initiated | 2016-11-21 |
| Classified | 2017-01-05 |
| Reported by FDA | 2017-01-11 |
| Terminated | 2017-01-05 |
| Distributed | Nationwide (US) |
| Quantity | 29 |
| Reason classes | sterility |
| Lot numbers | 160294 |
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 for recall
Endotoxin values from testing of retains slightly exceeded the established specification.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0948-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.