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U.S. Department of Health and Human Services

Class 2 Device Recall SPEED 15X12X12mm Continuous Compression Implant

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  Class 2 Device Recall SPEED 15X12X12mm Continuous Compression Implant see related information
Date Initiated by Firm September 27, 2022
Date Posted October 18, 2022
Recall Status1 Open3, Classified
Recall Number Z-0099-2023
Recall Event ID 90918
510(K)Number K142292  
Product Classification Staple, fixation, bone - Product Code JDR
Product SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512
Code Information UDI-DI (GTIN): 00810633020166 Lot/Expiry MSE220445 7/1/2027 MSE210184 8/1/2026
Recalling Firm/
Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
Manufacturer Reason
for Recall
The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.
FDA Determined
Cause 2
Error in labeling
Action On September 27, 2022, the firm notified affected customers via urgent medical Device Recall letters. Customers were instructed to examine their inventory to determine if they have affected product and to quarantine them immediately - Customers should not use the recalled products. Customers should contact their DePuy Synthes Sales Consultant or call the customer support services at ra-dpyus-csspecial@its.jnj.com to coordinate the return/credits of the subject products.
Quantity in Commerce 94 US; 30 OUS
Distribution US Nationwide distribution.
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 = JDR and Original Applicant = BioMedical Enterprises, Inc.