Device product
Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System
Z-1776-2022
Product summary
- Firm
- Paragon 28, Inc.
- Event
- Event 90753
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 145
- Official record key
device-enforcement:Z-1776-2022
Official wording
Reason: Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.
Code information: UDI-DI: 00889795114228, Lot: 5007499
Distribution pattern: US Nationwide distribution in the states of AZ, IN, LA, NJ, TX, WA, NY, MD, WI, OK, KY, MI, OH, CA, FL, KS, PA.
Derived failure modes
-
Unknown
Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.