Home / Recalls / TEI Biosciences, Inc. / Z-2072-2023

Z-2072-2023 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
2,392 units

Product Description

SurgiMend 2.0; 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, 20x25cm, 10x15cm Semi-Oval,

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): 606-200-002 (10381780112976), 606-200-004 (10381780112983), 606-200-006 (10381780112990), 606-200-008 (10381780113003), 606-200-009 (10381780113010), 606-200-016 (10381780113027), 606-200-017 (10381780113034), 606-200-019 (10381780113041), 606-200-020 (10381780113058), and 606-204-100 (10381780113065).

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)