Class 2 Device Recall MONOCRYL

• Date Initiated by Firm: October 08, 2024
• Date Posted: November 19, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0487-2025
• Recall Event ID: 95583
• 510(K)Number: K964072
• Product Classification: Suture, absorbable, synthetic - Product Code GAN
• Product: MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and neurological tissues, microsurgery or ophthalmic surgery.
• Code Information: Product Number: Y936H UDI-DI code: 10705031059917 Lot Number: TMMDQD
• Recalling Firm/ Manufacturer: ETHICON, INC.; Calle Durango 2751; Col. Parque Industrial Americas, Juarez; Juarez Mexico
• For Additional Information Contact: Ethicon Resource Department; 877-3844266
• Manufacturer Reason for Recall: Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
• FDA Determined Cause: Process control
• Action: On 10/08/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL (REMOVAL)" Letter via UPS 2nd Day Air to customers informing them that due to a manufacturing component error/mix, Monocryl Suture, Product Code Y936H, Lot TMMCQD may contain some packages with incorrect needle type/size and suture diameter/length. Customers are instructed to: 1. Examine inventory immediately and quarantine such product(s). Maintain/keep a copy of this notice with the quarantined product and your records. 2. Communicate the issue to relevant personnel, or anyone else who needs to be informed. If any product has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 3. Complete the Business Reply Form (BRF) (Attachment 2) confirming receipt of this notice and fax 800-766-5841 or email ethicon2852@sedgwick.com to Sedgwick within three business days. Return the BRF even if you do not have product subject to this recall. 4. Immediately return all unused Monocryl" (poliglecaprone 25) Suture subject to this recall (Product Code Y936H, Lot TMMDQD) in inventory. To receive replacement product, return product subject to this recall no later than December 31, 2024 to Sedgwick. Any non-affected product and any product returned after the date specified will not be eligible for credit reimbursement. 5. To return product, photocopy completed BRF, place in the box with the product, and affix the pre-paid authorized shipping label. Ethicon will pay for the shipping charges only if the authorized label is used. For extra shipping labels call Sedgwick at 888-203-3152. Your account number and mailing address have been pre-populated on the BRF. 6. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. If you require any assistance with returning product, please contact Sedgwick at 888-203-3152 and reference Event # 2852.
• Quantity in Commerce: 16,524 devices
• Distribution: U.S.: AK, AL, AR, AZ, CA, CO,CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. O.U.S.: Not provided.
• 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 = GAN