FDA recall Z-1776-2022

Paragon 28, Inc. · Class II · device

Product

Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System

Reason for recall

Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.

Distribution

US Nationwide distribution in the states of AZ, IN, LA, NJ, TX, WA, NY, MD, WI, OK, KY, MI, OH, CA, FL, KS, PA.

Key facts

Status
Ongoing
Initiation date
2022-07-13
Report date
2022-09-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Englewood, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1776-2022