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U.S. Department of Health and Human Services

Class 2 Device Recall Codman Surgical Patties

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  Class 2 Device Recall Codman Surgical Patties see related information
Date Initiated by Firm December 02, 2022
Date Posted January 06, 2023
Recall Status1 Open3, Classified
Recall Number Z-0909-2023
Recall Event ID 91280
510(K)Number K193346  
Product Classification Neurosurgical paddie - Product Code HBA
Product Codman Surgical Patties, Part number 801400; SURG PATXRAY
1/2X1/2-200; Lot 6396457
Code Information UDI-DI 10381780514961 Lot Number: 6396457 Expiration date 06/30/2027
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
1100 Campus Rd
Princeton NJ 08540-6650
For Additional Information Contact Lacey Gigante
609-212-9004
Manufacturer 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.
FDA Determined
Cause 2		 Process control
Action On December 2, 2022, the firm notified customers via "URGENT VOLUNTARY MEDICAL DEVICE RECALL" letters. Customers were instructed to immediately remove units of affected product from service. Customers should complete the Acknowledgement Form and return to the recalling company. Once received, Customer Service will contact the customer to aid them in returning the affected product. Should you have any questions regarding these instructions, please contact Customer Service: Monday to Friday 8:00 AM 8:00 PM EST USA: 1-800-654-2873: email: custsvcnj@integralife.com
Quantity in Commerce 168 US; 3 OUS
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HBA and Original Applicant = Integra LifeSciences Corporation
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