RecallRadar

FDA Device recall Z-1776-2022

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

On 2022-09-28 the FDA classified a Class II recall of Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System by Paragon 28, citing suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1776-2022
ClassificationClass II
Statusongoing
Initiated2022-07-13
Published2022-09-28
Last updated2026-09-13 11:56 UTC
CompanyParagon 28
DistributionUS

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.

Identifiers

code_infoUDI-DI: 00889795114228, Lot: 5007499

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1776-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.