Paragon 28, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1776-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: July 13, 2022

Date Posted: September 28, 2022

Recall Number: Z-1776-2022

Event ID: 90753

Reason for Recall:

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

Status: Ongoing

Product Quantity: 145

Code Information:

UDI-DI: 00889795114228, Lot: 5007499

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated