Use cautionMedical device recall · FDA · Published July 13, 2022
Paragon 28 Grappler Suture Anchor Recall: Risk of Breakage During Surgery
Paragon 28 recalls titanium suture anchors that may break during surgery, causing debris and delays. Affected kits include REF P44-110-3010-SK. Contact for return instructions.
“Paragon 28 Grappler Suture Anchor Recall: Risk of Breakage During Surgery.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/60370-paragon-28-grappler-suture-anchor-recall-risk-of-breakage-during. Based on FDA recall #Z-1776-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1776-2022%22&limit=1).
The FDA announced on July 13, 2022, that Paragon 28, Inc. is recalling Grappler Suture Anchors because the titanium anchors may break upon insertion. This defect could lead to debris in patients and delays in surgery.
How to tell if you have it
Brand: Paragon 28
Product: Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit
REF: P44-110-3010-SK
UDI-DI: 00889795114228
Lot: 5007499
Quantity: 145 units
Distribution: US Nationwide, including AZ, IN, LA, NJ, TX, WA, NY, MD, WI, OK, KY, MI, OH, CA, FL, KS, PA
The hazard
According to the FDA, the suture anchor may break upon insertion. This could lead to potential debris in the patient and delays in surgery.
Context
GovInfoNow's records show Paragon 28, Inc. has 9 other recalls on record since December 19, 2017. Other recent recalls of similar products include Aju Pharm Genesis Dual Thread Screw-In Anchor Recall (December 17, 2025), Genesis Push-In Suture Anchor Recall (December 17, 2025), and Genesis Knotless Anchor Recall (December 17, 2025).
How to tell if you have this one
Check for the product name 'Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit' with reference number P44-110-3010-SK. The UDI-DI code 00889795114228 and lot number 5007499 identify affected units.
Brand
Paragon 28
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the reference number P44-110-3010-SK and UDI-DI code 00889795114228 on the kit packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 17 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Florida, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas, Washington, Wisconsin.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1776-2022 (July 13, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1776-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.