Recall Z-1776-2022 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Paragon 28, Inc.
Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System
| Date | Sep 22, 2022 (initiated Jul 13, 2022) |
| Status | Open, Classified |
| Reason | Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery. |
| Root cause | Device Design |
| Action | 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 |
| Quantity | 145 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211002 | Grappler Suture Anchor System Paragon 28, Inc., Jul 7, 2021 |