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U.S. Department of Health and Human Services

Class 2 Device Recall Articul/eze Articul/eze Femoral Head

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  Class 2 Device Recall Articul/eze Articul/eze Femoral Head see related information
Date Initiated by Firm May 07, 2021
Create Date June 10, 2021
Recall Status1 Terminated 3 on March 09, 2023
Recall Number Z-1845-2021
Recall Event ID 87975
510(K)Number K843909  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
Product DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis.
Part Number: 1365-21-000, Part Description: ARTICUL/EZE BALL 32 +1 GR
Code Information Lot: D20111130 GTIN: 10603295033172
Recalling Firm/
Manufacturer		 DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact Shannon Rook
610-314-2088
Manufacturer Reason
for Recall		 Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product.
FDA Determined
Cause 2		 Employee error
Action On May 12, 2021, DePuy Synthes issued an Urgent Medical Device Removal notice to customers via letter notifying them that DePuy Synthes has determined that individual units of ARTICUL/EZETM Femoral Heads were distributed with the incorrect part number and size etched on the product. Please take the Following Steps: 1. Examine your inventory immediately to determine if you have the lot subject to this recall and quarantine the product. 2. Contact your DePuy Synthes Sales Consultant to coordinate the return of any products from the affected lot. 3. Complete, sign and return the attached business response form (see page 3 of this notice) to OneMD-Field-Actions@its.jnj.com 4. Forward this notice to anyone in your facility that needs to be informed (i.e., those who manage, transport, store, stock, or use the project subject to this recall). 5. If any of the subject product has been forwarded to another facility, contact that facility and provide them with this notice. 6. Post a copy of this notice in a visible area for awareness and keep a copy for your records.
Quantity in Commerce 50 units
Distribution Domestic: CA, CT, FL, GA, IA, IN, LA, ME, MN, MO, MT, NC, NE, NY, OH, OK, OR, PA, SC, TN, WI. Foreign: Bermuda
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 = JDI and Original Applicant = DEPUY, INC.
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