Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall PDS Plus

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall PDS Plussee related information
Date Initiated by FirmAugust 10, 2023
Date PostedSeptember 30, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2616-2023
Recall Event ID 92843
Product Classification Suture, surgical, absorbable, polydioxanone - Product Code NEW
ProductPDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50, PDP489H40, PDP497G51, PDP497H16, PDP497H40, PDP498H40, PDP502V05, PDP507V05, PDP510V05, PDP515V05, PDP662H50, PDP663H50, PDP684H40, PDP9615H40, PDP9625H40, PDP9626H40, PDP9631H40, PDP9715H15, PDP9715H40, PDP9733H16, PDP9861H40, PDP9865H40, XWPDP421H40, XWPDP423H40, XWPDP442H40, XWPDP443H16
Code Information UDI-DI: 10705031122574, 10705031047952, 10705031048232, 10705031048294, 10705031048300, 10705031048393, 10705031123786, 10705031048447, 10705031123854, 10705031123854, 10705031123861, 10705031203969, 10705031203983, 10705031204010, 10705031204034, 10705031048546, 10705031048553, 10705031124059, 10705031124677, 10705031124691, 10705031124707, 10705031124714, 10705031124752, 10705031124752, 10705031124769, 10705031124875, 10705031124899, 10705031123540, 10705031123564, 10705031123588, 10705031123595; Lot Numbers: RLMCKU, RLMEAL, RLMDST, RMMHLT, RJMMAC, SCMASA, RKMQDX, RKMBEB, SAMERU
Recalling Firm/
Manufacturer		 ETHICON, LLC
475 Calle C Ste 401
Guaynabo PR 00969-4292
Manufacturer Reason
for Recall		Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.
FDA Determined
Cause 2		Under Investigation by firm
ActionAn URGENT: MEDICAL DEVICE RECALL (REMOVAL) notification letter dated 8/10/23 was sent to customers. 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 Sedgwick at 877-550-0702 or Ethicon3541@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 PDS" Sutures subject to this recall that are in inventory immediately. To receive credit reimbursement, customers must return product subject to this recall no later than November 30, 2023. Any non-affected product and any product returned after the date specified will not receive credit reimbursement. 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 877-479-8088. 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. 7. If product subject to this recall is contained in a custom kit, please contact you
Quantity in Commerce868,363 total units
DistributionUS Nationwide. Global Distribution.
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.
-
-