Recall Z-0909-2023 ยท HBA Neurosurgical Paddie
Integra LifeSciences Corp.
Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
| Date | Jan 6, 2023 (initiated Dec 2, 2022) |
| Status | Open, Classified |
| 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. |
| 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: custsvcnj@integralife.com |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193346 | Codman Surgical Patties & Strips Integra LifeSciences Corporation, Nov 20, 2020 |