Z-0909-2023 Class II Ongoing
FDA device recall Z-0909-2023 was initiated by Integra LifeSciences Corp. on Dec 2, 2022 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 168 US; 3 OUS.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 18, 2023
- Initiation Date
- Dec 2, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 168 US; 3 OUS
Product Description
Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
Reason for Recall
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.
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.
Code Information
UDI-DI 10381780514961 Lot Number: 6396457 Expiration date 06/30/2027
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0909-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026