Paragon 28, Inc. 14445 Grasslands Dr Englewood CO 80112-7062 Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System
Brand
Paragon 28, Inc. 14445 Grasslands Dr Englewood CO 80112-7062
Lot Codes / Batch Numbers
UDI-DI: 00889795114228, Lot: 5007499
Products Sold
UDI-DI: 00889795114228, Lot: 5007499
Paragon 28, Inc. 14445 Grasslands Dr Englewood CO 80112-7062 is recalling Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the due to Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.
Recommended Action
Per FDA guidance
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 mkinnee@paragon28.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026