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U.S. Department of Health and Human Services

Class 2 Device Recall Drill guide for the JAWS Nitinol Staple System

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  Class 2 Device Recall Drill guide for the JAWS Nitinol Staple System see related information
Date Initiated by Firm December 19, 2017
Create Date June 20, 2018
Recall Status1 Terminated 3 on January 15, 2021
Recall Number Z-2261-2018
Recall Event ID 80181
510(K)Number K170923  
Product Classification Staple, fixation, bone - Product Code JDR
Product P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot including fixation of small bone fragments.
Code Information Part # P71-008-0808-S 8mm x 8mm x 8mm, Straight Lots 260315217A, 260322017A, 260326217A and 260326217B., Part # P71-010-1010-S 10mm x 10mm x 10mm, Straight Lots 260317717A, 260317717C, 260322017B, and 260326217D., Part # P71-108-0808-S 8mm x 8mm x 8mm, Angled, Lots 260322017C, 260322017D, 260315217B, and 260326217M. and  Part # P71-110-1010-S 10mm x 10mm x 10mm, Angled Lots 260326217E,  260317717B, 260322017E, 260322017F, 260322017G, 260326217F and 260326217G.
Recalling Firm/
Paragon 28, Inc.
4B Inverness Ct E Ste 280
Englewood CO 80112-5329
For Additional Information Contact Eric Pohl
Manufacturer Reason
for Recall
Missing drill guide as stated in the package.
FDA Determined
Cause 2
Error in labeling
Action The firm, Paragon 28 Inc. sent an "MEDICAL DEVICE RECALL" letter dated Dec 19, 2017 to their consignees. The letter describes the product, problem and actions to be taken. The consignees were instructed to immediately review their inventory to determine if they have the devices; if you have possession of any of the devices, you must ship entire kit back to Paragon 28 Inc., 96 Inverness Drive, E. ste 1; Englewood CO 80112. If you have any questions, contact Senior Quality Manager at 720-643-1301 or email to: epohl@paragon28.com.
Quantity in Commerce 1,626
Distribution Worldwide Distribution: US (nationwide) to states of: AL, AZ, CA, CO, DC, FL, GA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, NC, NJ, NV, NY, OH, OR, PA, SC, TN, TX, VA, WA, and WI; to countries of: Australia and South Africa.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JDR and Original Applicant = Paragon 28