Z-1776-2022 Class II Ongoing
FDA device recall Z-1776-2022 was initiated by Paragon 28, Inc. on July 13, 2022 and is designated Class II. Reason for recall: Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery. The recall status is ongoing. Affected quantity: 145.
Recall Details
- Product Type
- Devices
- Report Date
- September 28, 2022
- Initiation Date
- July 13, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 145
Product Description
Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System
Reason for Recall
Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.
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.
Code Information
UDI-DI: 00889795114228, Lot: 5007499