FDA recall Z-1534-2024

Product

POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N

Reason for recall

Complaints have been received with allegations of Incorrect Needle Curvature.

Distribution

Domestic: AZ, CA, IL, MA, MD, MN, NJ, PA and TX. International: New Zealand.

Key facts

Status

Ongoing

Initiation date

2024-03-26

Report date

2024-04-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Westwood, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1534-2024