FDA recall Z-1773-2022

Product

PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles

Reason for recall

Product may contain the incorrect material which could impact treatment.

Distribution

Distribution in Japan only

Key facts

Status

Ongoing

Initiation date

2022-08-08

Report date

2022-09-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Somerville, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1773-2022