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Recall Observatory FDA recall evidence

Device product

SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm x 20cm

Z-2076-2023

May 23, 2023

Class II

Product summary

Firm
TEI Biosciences, Inc.
Event
Event 92481
Status
Ongoing
Classification
Class II
Quantity
9,215 units
Official record key
device-enforcement:Z-2076-2023

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. 606-907-001. No UDI-DI (Distributed in Canada and EU).

Distribution pattern: Domestic: Nationwide Distribution.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification