FDA recall Z-0989-2020

Product

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

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.

Distribution

Domestic distribution nationwide. US and Puerto Rico only.

Key facts

Status

Terminated

Initiation date

2020-01-03

Report date

2020-02-12

Termination date

2021-08-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Somerville, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0989-2020