Home / Recalls / TEI Biosciences, Inc. / Z-2074-2023

Z-2074-2023 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
13,390 units

Product Description

SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25 cm, 1x5 cm, 10x25 cm 4x7cm Fenestrated, and 10x25 cm Fenestrated.

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): 606-300-002 (10381780113072), 606-300-004 (10381780113089) 606-300-006 (10381780113096), 606-300-008 (10381780113102), 606-300-009 (10381780113119), 606-300-016 (10381780113126), 606-300-017 (10381780113133), 606-300-019 (10381780113140), 606-300-020 (10381780113157), 606-300-021 (10381780113164), 606-300-022 (10381780113171), 606-304-001 (10381780113188), and 606-304-002 (10381780113195).

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-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)
  • Z-2084-2023 Class II — Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm (May 23, 2023)