Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System
FDA Recall Z-1776-2022 · Posted 2022-09-22
Advertisement
Recalling FirmParagon 28, Inc.
Recall StatusOpen, Classified
Product CodeMBI
Date Initiated2022-07-13
Product Quantity145
Reason for Recall
Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.
Firm 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 [email protected]
Root Cause
Device Design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement