Class 2 Device Recall CODMAN RANEY SCALP CLIPS

• Date Initiated by Firm: June 01, 2021
• Create Date: August 06, 2021
• Recall Status: Terminated on January 27, 2023
• Recall Number: Z-2224-2021
• Recall Event ID: 88312
• Product Classification: Clip, scalp - Product Code HBO
• Product: CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge.; Part Number: 201037
• Code Information: Lot Numbers: W2102045, W2102046, W2102048 and W2102049 GTIN# 10381780511625
• Recalling Firm/ Manufacturer: Integra LifeSciences Corp.; 1100 Campus Rd; Princeton NJ 08540-6650
• For Additional Information Contact: Lacey Gigante" Address: 1100 Campus Rd, Princeton, NJ 08540 " Telephone: 609-212-9004 " Email: ; 609-212-9004
• Manufacturer Reason for Recall: Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's sterile barrier
• FDA Determined Cause: Process change control
• Action: Integra notified consignees (Hospitals, Government facilities, and Distributors) by letter via FedX 2 Day Mail on June 1, 2021 and email to Distributor. Letter states reason for recall, health risk and action to take: We request that you take the following actions: 1. Customers a. If you do have units of the affected product listed in Table 1, remove it immediately from service. b. If you do have affected product, check the box on the enclosed form I do have affected product. Record the total quantity of the affected product that you have. c. If you do not have affected product, check the box, I do not have affected product. d. Complete the attached Acknowledgement Form and return to FCA2@integralife.com or FAX to 1-609-750-4220. e. Keep a copy of the form for your records. f. When your form is received, and it is noted that you have affected product, Customer Service will contact you and provide a Return Material Authorization (RMA) number and directions to return the affected product. A replacement order will also be placed for the quantity noted on the form. 2. Distributors a. If you do have the affected product listed in Table 1, remove the product from further distribution. b. Complete the attached form. If you do not have affected product, check the box, I do not have affected product . c. If you do have affected product, check the box I do have affected product . Record the total quantity of affected product you have. d. Complete the attached Acknowledgement Form and return to FCA2@integralife.com or FAX to 1-609-750-4220. e. Keep a copy of the form for your records. f. Please check your customer traceability records for shipments of above catalog numbers. g. Forward a copy of the enclosed Field Safety Notice to any of your customers that have purchased the above catalog and lot number. h. When the form from you and your customer is received, and it is noted that you or your customer has affected product, Customer Service will co
• Quantity in Commerce: 906 units
• Distribution: US Nationwide Distribution - Foreign Distribution: Hong Kong
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.