Skip to content

Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM)… recallZ-0319-2025 · Ethicon, Inc. · initiated Sep 25, 2024

Class II Open, Classified All recalls posted in November 2024

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

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 root cause category: Under Investigation by firm

What the company is doing

An 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

Recall details

Recall number
Z-0319-2025
Recall class
Class II
Status
Open, Classified
Initiated by the company
Sep 25, 2024
Posted by the FDA
Nov 7, 2024
Recalling firm
Ethicon, Inc.
Quantity
31,032 units
Product code
GAM
FDA submissions
K183183
Distribution
International distribution to the country of China.

Product description

Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H

Code information (models, lots, serial numbers)

UDI-DI: 10705031237308 (each); 30705031237302 (box); Lot Number: QP2AJM

Other devices under the same FDA submission

37 devices cleared under K183183 — 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

How recalls are matched to devices · Editorial policy · Report an error on this page