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U.S. Department of Health and Human Services

Class 2 Device Recall SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK

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 Class 2 Device Recall SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCKsee related information
Date Initiated by FirmJanuary 03, 2020
Date PostedFebruary 13, 2020
Recall Status1 Terminated 3 on August 12, 2021
Recall NumberZ-1169-2020
Recall Event ID 84714
510(K)NumberK043223 
Product Classification Instrument, cutting, orthopedic - Product Code HTZ
ProductSPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block.
Code Information Lot SO2040929 ***Updated 7/9/20*** Lot SO2040602 Lot SO2037408 (None of this lot distributed in the US / OUS distribution only) 
Recalling Firm/
Manufacturer		 DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information ContactScientific and Medical Affairs mailbox
866-811-9367
Manufacturer Reason
for Recall		The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery.
FDA Determined
Cause 2		Process control
ActionThe recalling firm notified customers with emailed Urgent Recall Notices on January 3, 2020. The letter instructed customers to do the following: 1. Cease further distribution or use of the affected products and quarantine. 2. Contact your DePuy Synthes Sales Consultant to coordinate the return and of any affected devices. Director Materials Management / Operating Room Supervisor / Risk Managers / Field Action Coordinators and Surgeons 3. Review, complete, sign and return the business reply form (BRF) to DePuy Synthes (DPYUS-JointReconFieldActions@its.jnj.com) within 5 business days of receipt of this notification. 4. Forward this notice to anyone in your facility that needs to be informed, including surgeons who may have used this product. 5. If any impacted products have been forwarded to another facility, contact that facility and provide them with this letter. For clinical questions from surgeons, please contact DePuy Synthes Scientific and Medical Affairs mailbox RA-DPYUS-DePSynSc@ITS.JNJ.com. ***Updated 7/9/2020*** Firm sent out new notifications dated July 13, 2020 communicating that event has expanded to include two additional lots.
Quantity in Commerce140 total units
DistributionDomestic distribution to IA, MA, NY, OH, and PA. Foreign distribution to Canada, China, Hungary, United Kingdom, and Singapore. ***Updated 7/9/20*** Expanded notice includes 6 new countries: Belgium, France, Germany, Maldives, New Zealand, and UAE
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HTZ
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