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U.S. Department of Health and Human Services

Class 2 Device Recall Grappler Suture Anchor, Titanium,

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  Class 2 Device Recall Grappler Suture Anchor, Titanium, see related information
Date Initiated by Firm July 13, 2022
Date Posted September 22, 2022
Recall Status1 Open3, Classified
Recall Number Z-1776-2022
Recall Event ID 90753
510(K)Number K211002  
Product Classification Fastener, fixation, nondegradable, soft tissue - Product Code MBI
Product Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System
Code Information UDI-DI: 00889795114228, Lot: 5007499
Recalling Firm/
Manufacturer		 Paragon 28, Inc.
14445 Grasslands Dr
Englewood CO 80112-7062
For Additional Information Contact Mandy Kinnee
888-728-1888
Manufacturer Reason
for Recall		 Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MBI and Original Applicant = Paragon 28, Inc.
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