Class 2 Device Recall ReNew brand by Microline Microscissor Tip (Disposable)

• Date Initiated by Firm: November 05, 2024
• Date Posted: December 10, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0663-2025
• Recall Event ID: 95734
• 510(K)Number: K213127
• Product Classification: Electrosurgical, cutting & coagulation & accessories - Product Code GEI
• Product: Microscissor Tip (Disposable); Microline Catalog #: 3122.
• Code Information: Microline Catalog #: 3122; UDI/DI: 811099010036; Lot Number: 00172110.
• Recalling Firm/ Manufacturer: Microline Surgical, Inc.; 50 Dunham Rd Ste 1500; Beverly MA 01915-1882
• For Additional Information Contact: Scott Marchand Davis ; 978-867-1758
• Manufacturer Reason for Recall: A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink breaking off.
• FDA Determined Cause: Under Investigation by firm
• Action: On November 6, 2024 URGENT: MEDICAL DEVICE RECALL letters were sent to consignees. Actions to be taken by the Customer/User: Please locate those products you have that correspond with the above identified lots, quarantine them, and arrange for their return by contacting Microline Customer Service to receive an RMA number. Alternatively, you may wish to contact your Microline Distributor or Sales Representative to help with this. If you have used some or all of the identified product, please provide the item number, lot number, and the amount used so that we can track the progress of the recall. All products returned will be replaced at no cost. This recall is being done in an abundance of caution. No other item numbers or lots of ReNew Disposable Tips are affected by this recall. If you experience any adverse events or quality problems with the use of this product, please be sure to report this to the relevant Competent Authority s Adverse Event Reporting Program and to Microline as soon as possible. We regret any inconvenience and encourage you to contact Microline Customer Service at 978- 922-9810 or info@microlinesurgical.com. with any further questions. Actions to be taken by the Distributor: 1. Immediately determine if you are in possession of the products subject to this recall by checking the product name, item number, and lot number. 2. If you are a distributor of products subject to this recall, we require that you immediately remove affected products from inventory, quarantine products, and stop sales and shipping. 3. If you are a distributor and you have further distributed products subject to this recall, please identify customers immediately and notify them of this product recall using this Recall Notification Letter. Translation of this letter into local language is acceptable. We request that you direct your customers to return affected products to your facility for subsequent return to Microline. The relevant Competent Authority will be monitoring th
• Quantity in Commerce: 200 units
• Distribution: Worldwide - US Nationwide in the state of OK and the country of Japan.
• 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 = GEI