Reported Sep 28, 2022 · Ongoing
Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture…
Paragon 28, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Paragon 28, Inc. · 14445 Grasslands Dr · Englewood, CO · 80112-7062
Is this the product you have?
- Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit
- REFP44-110-3010-SK, for use within the Grappler Suture Anchor System
- Lot codes and dates
- UDI-DI00889795114228
- Lot5007499
- Amount recalled
- 145
Where it was sold
Why it was recalled
Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.
This product could cause temporary or reversible health problems — stop using it.
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