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Sign in to claim this brandTEI BIOSCIENCES INC.
United States·US-MF-000012766
Last updated May 27, 2026
Information
- Country
- United States
- Address
- 7, Elkins Street, Boston, MA, United States
- Website
- integralife.com
- —
- —
- [email protected]
- Phone
- 8572054033
- PRRC Contact
- Waqar Zaidi
- EUDAMED SRN
- US-MF-000012766
- FDA FEI Number
- —
- DUNS Number
- 796253292
Catalogue (159)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Xenform Soft Tissue Repair Matrix | K051190 | FDA 510(k) | Class II | Active |
| Orthomend Soft Tissue Matrix | K071807 | FDA 510(k) | Class II | Active |
| Primatrix Dermal Repair Scaffold | K061407 | FDA 510(k) | U | Active |
| SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction | K162965 | FDA 510(k) | Class II | Active |
| Surgimend | K083898 | FDA 510(k) | Class II | Active |
| Primatrix Ag Antimicrobial Dermal Dermal Repair Scaffold | K100261 | FDA 510(k) | U | Active |
| Orthomend | K031188 | FDA 510(k) | Class II | Active |
| Dressskin | K023778 | FDA 510(k) | U | Active |
| PriMatrix Dermal Repair Scaffold | K153690 | FDA 510(k) | U | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (18)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| May 23, 2023 | Z-2075-2023 | — | open, classified | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| May 23, 2023 | Z-2085-2023 | — | open, classified | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| May 23, 2023 | Z-2072-2023 | — | open, classified | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| May 23, 2023 | Z-2080-2023 | — | open, classified | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| May 23, 2023 | Z-2069-2023 | — | open, classified | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| May 23, 2023 | Z-2079-2023 | — | open, classified | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| May 23, 2023 | Z-2071-2023 | — | open, classified | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| May 23, 2023 | Z-2078-2023 | — | open, classified | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| May 23, 2023 | Z-2083-2023 | — | open, classified | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| May 23, 2023 | Z-2073-2023 | — | open, classified | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| May 23, 2023 | Z-2084-2023 | — | open, classified | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| May 23, 2023 | Z-2070-2023 | — | open, classified | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| May 23, 2023 | Z-2076-2023 | — | open, classified | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| May 23, 2023 | Z-2081-2023 | — | open, classified | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| May 23, 2023 | Z-2077-2023 | — | open, classified | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| May 23, 2023 | Z-2074-2023 | — | open, classified | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| May 23, 2023 | Z-2082-2023 | — | open, classified | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| Jun 15, 2017 | Z-0383-2018 | — | terminated | During Final Assembly Operation, it was noticed that some of the PriMatrix Instructions for Use (IFUs) from Lot RM1608011 Part 520-002v10 contained extra pages and/or missing pages: " 22 IFUs contained duplicate pages 15 - 26 & 51 - 62 and were also missing pages 27 - 50 " 3 IFUs were missing pages 27 - 50 " 1 IFU was missing pages 1 - 2 & 75 - 76 " 1 IFU was missing pages 15 - 62 While pages 27 50, 75 76, and 15 62 contain instructions written in a language other than English, pages 1 2 contain information regarding the indications for use, contraindications, device description, warning and precautions, and potential complications of the device. |