Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System
This recall is currently active, issued September 22, 2022. It was issued by Paragon 28, Inc. 14445 Grasslands Dr Englewood Co 80112-7062.
- Recall Initiated
- July 13, 2022
- Posted
- September 22, 2022
- Recall Number
- Z-1776-2022
- Quantity
- 145
- Official Source
- View on FDA website ↗
Reason for Recall
Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.
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.
Lot / Code Info
UDI-DI: 00889795114228, Lot: 5007499
Root Cause
Device Design
Action Taken
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