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Recall Observatory FDA recall evidence

Device product

PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, and 8x8 cm.

Z-2077-2023

May 23, 2023

Class II

Product summary

Firm
TEI Biosciences, Inc.
Event
Event 92481
Status
Ongoing
Classification
Class II
Quantity
4,159 units
Official record key
device-enforcement:Z-2077-2023

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): 607-001-009 (10381780113294), 607-001-112 (10381780113300), 607-001-125 (10381780113317), 607-001-225 (10381780113324), 607-001-440 (10381780113331), 607-001-660 (10381780113348), 607-001-812 (10381780113355), 607-001-880 (10381780113362).

Distribution pattern: Domestic: Nationwide Distribution.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification