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U.S. Department of Health and Human Services

Class 2 Device Recall VICRYL Suture

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 Class 2 Device Recall VICRYL Suturesee related information
Date Initiated by FirmSeptember 25, 2024
Date PostedNovember 07, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0319-2025
Recall Event ID 95516
510(K)NumberK183183 
Product Classification Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
ProductCoated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
Code Information UDI-DI: 10705031237308 (each); 30705031237302 (box); Lot Number: QP2AJM
Recalling Firm/
Manufacturer		 Ethicon, Inc.
1000 Route 202
Raritan NJ 08869-1425
For Additional Information ContactEthicon Customer Service
877-384-4266
Manufacturer Reason
for Recall		Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.
FDA Determined
Cause 2		Under Investigation by firm
ActionAn URGENT: FIELD SAFETY NOTICE was sent to customers beginning on 9/25/24. ACTION REQUIRED 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 [Enter Affiliate Information] 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 VICRYL" (polyglactin 910) Suture subject to this recall that are in inventory immediately. To receive credit or replacement product as appropriate, customers must return product subject to this recall no later than December 31, 2024 to [Enter Affiliate Information]. Any non-affected product and any product returned after the date specified will not be eligible for credit or replacement product. 5. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to [Enter Affiliate Information]. If you require any assistance with
Quantity in Commerce31,032 units
DistributionInternational distribution to the country of China.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GAM
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