Home / Recalls / TEI Biosciences, Inc. / Z-2085-2023

Z-2085-2023 Class II Ongoing

Recalled by TEI Biosciences, Inc. — Boston, MA

Recall Details

Product Type
Devices
Report Date
July 12, 2023
Initiation Date
May 23, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,832

Product Description

TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 cm, and 3x3 cm.

Reason for Recall

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

Distribution Pattern

Domestic: Nationwide Distribution.

Code Information

Item No. (UDI-DI): 6495-9-001 (10381780113621), 6495-9-004 (10381780113638), 6495-9-006 (10381780113645).

Other recalls by TEI Biosciences, Inc.

  • Z-2073-2023 Class II — SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x (May 23, 2023)
  • Z-2080-2023 Class II — PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 c (May 23, 2023)
  • Z-2076-2023 Class II — SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; S (May 23, 2023)
  • Z-2082-2023 Class II — PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x2 (May 23, 2023)
  • Z-2070-2023 Class II — SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10 (May 23, 2023)
  • Z-2081-2023 Class II — PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 (May 23, 2023)
  • Z-2083-2023 Class II — Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, (May 23, 2023)
  • Z-2074-2023 Class II — SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x (May 23, 2023)
  • Z-2078-2023 Class II — PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x (May 23, 2023)
  • Z-2077-2023 Class II — PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, (May 23, 2023)