Integra LifeSciences Holdings Corp.

The FDA said some recalled Codman perforators may have found their way into about 1,850 craniotomy kits from Medline. \n The FDA is amplifying an effort underway at medical device distributor Medline that aims to correct certain neurosurgery kits containing hardware that may cause bone drills to break apart during a craniotomy procedure.Previously, Integra LifeSciences launched a recall of some of its Codman disposable perforators due to an inadequate weld on the outer sleeve of the device. The company said the manufacturing defect may cause the 14mm perforator to disassemble, and, in some cases, prevent the device from automatically disengaging and stopping the drill’s rotation as designed.Earlier this month, the FDA said there have been 10 reported injuries but no deaths related to the issue—including complications from loose device fragments, plus skull and brain injuries, as well as the dangers in delaying the medical procedure itself. Integra’s Class I recall, first initiated in mid-April, spans more than 170,000 units. The company has directed healthcare providers to quarantine the affected products and return them for credit. The FDA said some of those recalled Codman perforators may have found their way into about 1,850 craniotomy kits from Medline, which also notified U.S. customers of the issue in April. This week, the agency spotlighted the distributor’s efforts to reach healthcare providers, which urged them to check their stock and affix warning labels that tell clinicians to remove the 14mm perforators before using the remainder of the kit.

This recall involves removing devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Manufacturer's Product Number (Catalog Number) Product Name (Description) UDI Number Lot Number Expiration Date 205000DS MicroMyst Applicator, Box of 5 10381780000112 All expired and unexpired lots All expired and unexpired lots What to Do Identify any affected products at your facility. Remove them from service and quarantine them. Discard expired lots. On May 23, 2025, Integra LifeSciences sent all affected customers an Urgent Voluntary Medical Device Recall letter recommending the following actions: For customers Determine if product you have is subject to the recall based on impacted part and lot number. Immediately remove any affected products from service and quarantine. Complete the acknowledgment form attached to the letter, even if you do not have affected product. Record the lot number and total quantity of affected product. Send completed acknowledgement form by email to FCA1@integralife.com or fax to 1-609-750-4220. After the acknowledgement form is received, customer service will provide a Return Material Authorization (RMA) number and directions to return affected product. You can request a credit for returned quantities. Note: Credit will only be given for the impacted lot(s) that are returned. Keep a copy of the form for your records. Forward the notice to people who use the product so they are aware of this recall and can identify and quarantine any affected product that may remain in clinical areas. For distributors/sales representatives Determine if product you have is subject to the recall based on impacted part and lot number. Remove any affected products from further distribution. Complete the acknowledgment form attached to the letter, even if you do not have affected product. Record the lot number and total quantity of affected product. Send completed acknowledgement form by email to FCA1@integralife.com or fax to 1-609-750-4220. After the acknowledgement form is received, customer service will provide a Return Material Authorization (RMA) number and directions to return affected product. You can request a credit for returned quantities. Note: Credit will only be given for the impacted lot(s) that are returned. Keep a copy of the form for your records. Check customer traceability records for shipments of affected catalog and lot numbers. If impacted product was shipped to customers, please: Create an acknowledgement form from you to your customers. Forward a copy of the notice and your acknowledgement form to any customers who purchased affected catalog and lot numbers. Collect completed response forms and affected product from your customers. Indicate total quantities and lots in the distributor reply form provided with the letter. After the acknowledgement form is received, customer service will provide a Return Material Authorization (RMA) number and directions to return affected product. Distributors can request a credit for returned quantities. Note: Credit will only be given for the impacted lot(s) that are returned. If you are a sales representative, Post Market Quality will contact you and provide you with directions to return the product after the acknowledgement form has been returned and indicates you have affected product. Reason for Recall Integra LifeSciences is recalling MicroMyst Applicators due to incomplete bioburden assessments and incomplete sterilization location transfer documentation, both of which help ensure the products were effectively sterilized. The use of affected product may cause serious adverse health consequences, including inflammation, infection, and death. Integra LifeSciences has not reported any serious injuries or deaths associated with this issue. Device Use The MicroMyst Applicator is intended for use in the delivery of the two DuraSeal precursor solutions onto a surgical site at the same time. It is a sterile, single-use device with a 14 cm, dual lumen, stainless steel cannula and an outer sheath used during surgical procedures. Contact Information Customers in the U.S. with questions about this recall should contact their Integra sales representative or customer service at 1-800-654-2873 or custsvcnj@integralife.com Additional FDA Resources: FDA’s Enforcement Report Medical Device Recall Database Unique Device Identifier (UDI) The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly. How do I report a problem? Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Content current as of: 07/21/2025 Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Product Name Unique Device Identifier (UDI) Codman Disposable Perforator 14 mm 10381780513599 Codman Craniotomy Kit Containing Disposable Perforator 14 mm, Cranio-blade, Wire Pass Drill 10381780513629 Lot/Serial Numbers: Full List of Affected Lots What to Do: Stop using and immediately quarantine all affected products. Review inventory and identify affected lot numbers using the provided lot list. On April 11, 2025, Integra LifeSciences sent all affected customers an Urgent Medical Device Recall Notification recommending the following actions: Stop using and quarantine all affected product immediately. Review your inventory and identify impacted lot numbers. Complete and return the appropriate Acknowledgement Form to Integra via email at FCA3@integralife.com or fax to 1-609-750-4220. Notify all appropriate clinical or distribution staff. Return affected product after receiving a Return Material Authorization (RMA). Credit will be provided for returned affected lots. Reason for Recall Integra LifeSciences is recalling specific Codman Disposable Perforators and Craniotomy Kits due to an inadequate ultrasonic weld (a “proud weld”) on the outer sleeve of the device. This weld defect may cause the perforator to disassemble before, during, or after use in craniotomy procedures. In some cases, the device may fail to disengage, preventing the device from stopping immediately. The use of affected product may cause serious adverse health consequences, including damage to the dura, bleeding, brain injury, extended surgery, irreversible brain damage, and death. There have been 10 reported injuries including those from procedural delay, device becoming lodged in the patient’s skull during use, difficulty removing device fragments, bleeding, dural injury, and cerebral injury. There have been no reports of death. Device Use Codman Disposable Perforators are single-use surgical tools used in neurosurgical procedures to drill access holes into the skull. They are designed to automatically disengage once drilling is complete. Contact Information Customers in the U.S. with questions about this recall should contact Integra LifeSciences at 1-800-654-2873. Additional FDA Resources (listed in order of most to least recent): FDA’s Enforcement Report: Medical Device Recall Database: Unique Device Identifier (UDI) The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly. How do I report a problem? Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Content current as of: 07/16/2025 Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.