Class 2 Device Recall STRATAFIX" Spiral MONOCRYL" Plus Bidirectional Knotless Tissue Control Device

• Date Initiated by Firm: March 08, 2024
• Date Posted: April 12, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1533-2024
• Recall Event ID: 94220
• 510(K)Number: K192580
• Product Classification: Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
• Product: STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM- Indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product Code: SXMP2B412
• Code Information: UDI/GTIN: 30705031464289 (box) 10705031464285 (pouch) Lot Number: SHBAEC Exp. Date: June 30, 2024
• Recalling Firm/ Manufacturer: Ethicon, Inc.; 1000 Route 202; Raritan NJ 08869-1425
• Manufacturer Reason for Recall: Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
• FDA Determined Cause: Under Investigation by firm
• Action: Ethicon issued Urgent: Medical Device Recall (Removal) Letter to Operating Room Supervisors, Materials Management Personnel, and Chief of Surgery via Third Party on March 8, 2024. Letter states reason for recall, health risk and action to take: 1. Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). If you have product subject to this recall, please maintain a copy of this notice with the quarantined product and keep a copy for your records. 2. Communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. If any product subject to this recall 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 3) confirming receipt of this notice and fax or email to Sedgwick at 855-207-2785 or ethicon7775@sedgwick.com within three (3) business days. Please return the BRF even if you do not have product subject to this recall. 4. Customers are required to return unused STRATAFIX" Spiral MONOCRYL" Plus Sutures subject to this recall that are in inventory immediately. To receive credit, customers must return product subject to this recall no later than June 30, 2024. Any non-affected product and any product returned after the date specified will not receive credit. 5. To return product subject to this recall, photocopy the completed BRF, place it in the box with the product, and affix the pre-paid authorized shipping label included with the recall notification letter. Ethicon will pay for the shipping charges only if the authorized label is used. Extra shipping labels may be obtained by calling Sedgwick at 855-215-5702. 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 t
• Quantity in Commerce: 395 units
• Distribution: CO GA IA MI NJ NY NY PA SC WI
• 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 = GAM