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Recall Observatory FDA recall evidence

Device product

Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457

Z-0909-2023

December 02, 2022

Class II

Product summary

Firm
Integra LifeSciences Corp.
Event
Event 91280
Status
Ongoing
Classification
Class II
Quantity
168 US; 3 OUS
Official record key
device-enforcement:Z-0909-2023

Official wording

Reason: Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patties is potentially a minor transient fever.

Code information: UDI-DI 10381780514961 Lot Number: 6396457 Expiration date 06/30/2027

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of CA, CO, CT, FL, IN, KY, MA, MI, MO, NC, NJ, NY, OH, PA, TX, VA, WV and the countries of Chile, Australia, New Zealand, France, Romania, United Kingdom, and Ireland.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out-of-specification