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U.S. Department of Health and Human Services

Class 2 Device Recall DePuy Mitek FMS Irrigation Intermediary Tube With Oneway Valve Arthroscopy tubing

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  Class 2 Device Recall DePuy Mitek FMS Irrigation Intermediary Tube With Oneway Valve Arthroscopy tubing see related information
Date Initiated by Firm December 03, 2010
Date Posted April 12, 2011
Recall Status1 Terminated 3 on April 02, 2013
Recall Number Z-1946-2011
Recall Event ID 57385
510(K)Number K951843  
Product Classification Arthroscope - Product Code HBX
Product DePuy Mitek FMS Irrigation Intermediary Tube With One-way Valve Arthroscopy tubing
Product Code: 281142
Fluid Tissue Management
Code Information Lot Codes: 1060792 1060824 1060841 1060851 BBBA0953D BBBA0953E BBBA0953F BBBA0953G BBBA1001T BBBA1001V BBBA1002H BBBA1002I BBBA1005D BBBA1005E BBBA1005F BBBA1005G BBBA1007J BBBA1008C BBBA1008E BBBA1010G BBBA1010H BBBA1010J BBBA1010K BBBA1012B BBBA1012C BBBA1012E BBBA1014A BBBA1014E BBBA1015F BBBA1015G BBBA1018E BBBA1018F BBBA1020B BBBA1020C 
Recalling Firm/
DePuy Mitek, Inc., a Johnson & Johnson Co.
325 Paramount Dr
Raynham MA 02767
For Additional Information Contact
Manufacturer Reason
for Recall
Product sterility may be compromised due to breach in sterile packaging
FDA Determined
Cause 2
Packaging process control
Action Depuy Mitek sent an Urgent Voluntary Product Recall letter dated December 2, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to isolate all inventory of the affected product and call 1-800-382-4682, PROMPT 3, for return good authorization and replacement product. Customers were instructed to return all identified affected product to: DePuy Mitek ATTN: Recall Coordinator 50 Scotland Boulevard Bridgewater, MA 02324 Record their assigned return material authorization (RMA) number on the outer shipping box. Use the Prepaid Federal Express shipping label for the return of the product. Include a photo copy of the completed business reply form. For questions or concerns call 1-800-382-4682, PROMPT 3.
Quantity in Commerce 50,376 units
Distribution Worldwide Distribution - USA (nationwide) and the coutnries of United Arab Emirates, Australia, Belgium, Switzerland, Czech, Denmark, France, UK, Italy, Netherlands, Poland, and Slovakia.
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 = HBX and Original Applicant = FUTURE MEDICAL SYSTEMS, INC.