Z-1776-2022Class II

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

Name: Z-1776-2022 Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler...
Creator: Paragon 28, Inc.
Published: 2022-07-13
License: https://open.fda.gov/license/

Paragon 28 / initiated 2022-07-13 / Open, Classified / root cause: design

FDA source

Paragon 28, Inc. began a 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 on 2022-07-13. FDA classified it as Class II and gives the reason as "Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1776-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-13
Posted: 2022-09-22
Recalling firm: Paragon 28
Product: Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
Reason for recall: Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.
Root cause tag: design
FDA root cause: Device Design
Action: On 7/13/22, recall notices were emailed to distributors who were asked to do the following: 1) Review physical inventory of product within your control and at a hospital/health care facility within your region. Any affected product that is identified is to be discontinued, quarantined and not distributed any further. 2) Return affected devices to the recalling firm. 3) Complete and return the Recall Response form. For inquiries, contact the recalling firm at [email protected]
Quantity in commerce: 145
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.
Product codes and lots: UDI-DI: 00889795114228, Lot: 5007499

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1776-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1776-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-28	2022-09-22

Product code MBI

K211002Class IIGrappler Suture Anchor SystemParagon 28, Inc. / cleared 2021-07-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)