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Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product… recallZ-0989-2020 · Ethicon, Inc. · initiated Jan 3, 2020

Class II Terminated All recalls posted in February 2020

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

Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point.

FDA root cause category: Process control

What the company is doing

The firm notified customers of the recall on January 3, 2020. Customers were informed to immediately cease usage or distribution of the recalled lot. All unused product subject to the recall is to be returned to the firm. If any recalled product was forwarded to another facility, contact that facility to arrange return. Customers were also asked to complete and return the included business reply form to the recalling firm even if they did not have product subject to this recall. In addition, customers are to keep the recall notice visibly posted for awareness until all product subject to this recall has been returned to Stericycle. If you require any assistance with returning product, please contact Stericycle at 877-550-0701 and reference Event # 3453. Health care practitioners who have treated patients using this product should follow those patients post-operatively in the usual manner with no additional action required. If you have additional questions regarding this recall or to report any customer complaints, please contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266). The Customer Support Center is open Monday through Friday, 7:30 AM to 6:30 PM ET.

Recall details

Recall number
Z-0989-2020
Recall class
Class II
Status
Terminated
Initiated by the company
Jan 3, 2020
Posted by the FDA
Feb 4, 2020
Recalling firm
Ethicon, Inc.
Quantity
23688 units
Product code
GAM
FDA submissions
K022269
Distribution
Domestic distribution nationwide. US and Puerto Rico only.

Product description

Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.

Code information (models, lots, serial numbers)

lot PGZ908

Other devices under the same FDA submission

145 devices cleared under K022269 — 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