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

FDA device recall Z-0989-2020 · posted 2020-02-04 · Terminated

Recall details

Recalling firm

Ethicon, Inc.

Reason for recall

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

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

GAM

Quantity affected

23688 units

Distribution

Domestic distribution nationwide. US and Puerto Rico only.

Date initiated

2020-01-03

Date posted

2020-02-04

Date terminated

2021-08-13

Location

Somerville, NJ

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