Z-0909-2023Class II

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

Name: Z-0909-2023 Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
Creator: Integra LifeSciences Corp.
Published: 2022-12-02
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2022-12-02 / Open, Classified / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. began a recall of Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457 on 2022-12-02. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0909-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-02
Posted: 2023-01-06
Recalling firm: Integra LifeSciences Corporation
Product: Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
Product code: HBA Neurosurgical Paddie
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.
Root cause tag: manufacturing process
FDA root cause: 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: [email protected]
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.
Product codes and lots: UDI-DI 10381780514961 Lot Number: 6396457 Expiration date 06/30/2027

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0909-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0909-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-06

Product code HBA

K193346Class IICodman Surgical Patties & StripsIntegra LifeSciences Corporation / cleared 2020-11-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)