Ethicon, Inc. Us PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery
Brand
Ethicon, Inc. Us
Lot Codes / Batch Numbers
UDI-DI: 10705031060623 (individual unit), 30705031060634 (sales unit box) Lot: SCMSHK Exp. Date: February 28, 2027
Products Sold
UDI-DI: 10705031060623 (individual unit); 30705031060634 (sales unit box) Lot: SCMSHK Exp. Date: February 28, 2027
Ethicon, Inc. Us is recalling PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in s due to knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rat. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than premature post-operative breakage
Recommended Action
Per FDA guidance
Ethicon notified the four impacted countries via "URGENT: MEDICAL DEVICE RECALL (REMOVAL)" beginning Nov 16, 2022. Letter states reason for recall, health risk and actions to be taken. The customers were instructed to: Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). 2. Remove the product subject to this recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3. 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. 4. Complete the Business Reply Form (BRF) (Attachment 2) confirming receipt of this notice and return to Ethicon, Inc. within three (3) business days. Please return the BRF even if you do not have product subject to this recall. 5. Keep this notice visibly posted for awareness until all product subject to this recall has been returned. While processing your returns, please maintain a copy of this notice with the product subject to this recall and keep a copy for your records. 6. Customers are required to return unused PDS" II products subject to this recall that are in inventory immediately. To receive credit reimbursement, customers must return product subject to this recall to Ethicon, Inc. Any non-affected product and any product returned after the date specified will not receive credit reimbursement. If you have any questions, call 908-218-0707.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026