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U.S. Department of Health and Human Services

Class 2 Device Recall DePuy Mitek FMS Irrigation Intermediary Tube Without Oneway Valve Arthroscopy tubing

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  Class 2 Device Recall DePuy Mitek FMS Irrigation Intermediary Tube Without 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-1948-2011
Recall Event ID 57385
510(K)Number K951843  
Product Classification Arthroscope - Product Code HBX
Product DePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy tubing (100 units/box)
(International Distribution Only)
Product Code: 281102
Fluid Tissue Management
Code Information Lot Codes: 1060789 1060823 1060838 1060848 1061291 1061292 BBBA1001I BBBA1003D BBBA1003E BBBA1004A BBBA1006F BBBA1007D BBBA1008A BBBA1010A BBBA1011D BBBA1014B BBBA1015R BBBA1018G BBBA1019E 
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 92,000 units (920 boxes/100)
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.