Recall Z-1776-2022— Paragon 28, Inc.

Name: FDA recall Z-1776-2022
Creator: U.S. Food and Drug Administration
Published: 2022-07-13

Class II · Ongoing

Class II FDA medical device recall by Paragon 28, Inc., initiated 2022-07-13. It names one FDA 510(k) clearance: K211002. 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: Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery..

Recalling firm: Paragon 28, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-07-13
Firm location: Englewood, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K211002 — Grappler Suture Anchor SystemParagon 28, Inc.·cleared 2021-07-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.