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U.S. Department of Health and Human Services

Class 2 Device Recall FMS neXtra 3.5mm Aggressive Cutter Shaver Blades

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  Class 2 Device Recall FMS neXtra 3.5mm Aggressive Cutter Shaver Blades see related information
Date Initiated by Firm November 20, 2015
Date Posted January 15, 2016
Recall Status1 Terminated 3 on April 12, 2017
Recall Number Z-0657-2016
Recall Event ID 72697
510(K)Number K041824  
Product Classification Arthroscope - Product Code HRX
Product FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315

Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
Code Information Lot Number: M1505053
Recalling Firm/
Manufacturer		 DePuy Mitek, Inc., a Johnson & Johnson Co.
325 Paramount Drive
Raynham MA 02767-5199
For Additional Information Contact Elizabeth Messana
508-828-3150
Manufacturer Reason
for Recall		 Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
FDA Determined
Cause 2		 Process control
Action On November 20, 2015, customers were notified of the recall via letter. They were asked to take the following actions: Customer immediate actions: 1. Review inventory located within your facility and quarantine any products listed in this product recall notification. Please follow the instructions on the Business Reply Form to return any affected inventory located within your facility; 2. Review, complete, sign and return the attached business reply form to Elizabeth Messana (emessan1@its.jnj.com) in accordance with the directions on the business reply form within 5 business days of receipt of this notification; 3. Forward this notice to anyone in your facility that needs to be informed; 4. If any potentially affected product has been forwarded to another facility, contact Elizabeth Messana at 508-828-3150; 5. Keep a copy of this notice.
Quantity in Commerce 45 units
Distribution Worldwide Distribution. US states of TX, OH, MI, and ME; and the countries of FR, DE, SK, IT, NL, CH, and CZ.
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 = HRX and Original Applicant = FUTURE MEDICAL SYSTEMS, SA
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