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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 tubingsee related information
Date Initiated by FirmDecember 03, 2010
Date PostedApril 12, 2011
Recall Status1 Terminated 3 on April 02, 2013
Recall NumberZ-1947-2011
Recall Event ID 57385
Product Classification Arthroscope - Product Code HBX
ProductDePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy tubing Product Code: 281103 Fluid Tissue Management
Code Information Lot Codes: 1060790 BBBA1001N BBBA1005C BBBA1006G BBBA1014C 
Recalling Firm/
Manufacturer		 DePuy Mitek, Inc., a Johnson & Johnson Co.
325 Paramount Dr
Raynham MA 02767
For Additional Information Contact
508-880-8100
Manufacturer Reason
for Recall		Product sterility may be compromised due to breach in sterile packaging
FDA Determined
Cause 2		Packaging process control
ActionDepuy 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 Commerce7344 units (372 boxes x 24 pieces)
DistributionWorldwide 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 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.
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