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Recall Observatory FDA recall evidence

Device product

PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and 10x25 cm (Meshed 2:1).

Z-2078-2023

May 23, 2023

Class II

Product summary

Firm
TEI Biosciences, Inc.
Event
Event 92481
Status
Ongoing
Classification
Class II
Quantity
30,528 units
Official record key
device-enforcement:Z-2078-2023

Official wording

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

Code information: Item No. (UDI-DI): 607-004-440 (10381780113379), 607-004-660 (10381780113386), 607-004-880 (10381780113393), 607-005-014 (10381780357414), 607-005-018 (10381780357421), 607-005-125 (10381780113409), 607-005-220 (10381780357407).

Distribution pattern: Domestic: Nationwide Distribution.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification