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PDS Plus Antibacterial (polydioxanone) Suture - PDS PLUS… recallZ-1571-2023 · Ethicon, Inc. · initiated Mar 31, 2023

Class II Open, Classified All recalls posted in May 2023

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Ethicon, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved

FDA root cause category: Under Investigation by firm

What the company is doing

Ethicon issued Urgent Field Safety Notice Voluntary Product Recall (Removal) Letter for Johnson & Johnson Affiliates in the countries to contact primary and secondary consignees and/or end customers. Letter issued via email 3/31/23, 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). 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 [email protected] 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 Plus Antibacterial (polydioxanone) Suture products subject to this recall that are in inventory immediately. 7. To return product subject to this recall, please complete the declaration below advising of your contact and collection details and our returns team will contact you to arrange collection. If you require any assistance with returning product, please contact [email protected]. If you have any further questions related to this notice or if you need any additional communications, please contact your local Sales Representative.

Recall details

Recall number
Z-1571-2023
Recall class
Class II
Status
Open, Classified
Initiated by the company
Mar 31, 2023
Posted by the FDA
May 10, 2023
Recalling firm
Ethicon, Inc.
Quantity
1,656 eaches (OUS only)
Product code
NEW
FDA submissions
K061037
Distribution
International distribution in the countries of United Kingdom, Ireland and Turkey.

Product description

PDS Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatric cardiovascular tissue. Product Code: PDP9625H

Code information (models, lots, serial numbers)

UDI-DI: (01)10705031124691 Primary (Individual Unit); (01)30705031124695 (Sales Unit Box) Qty = 36 eaches. Lot Number: SCMAZH

Other devices under the same FDA submission

50 devices cleared under K061037 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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