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U.S. Department of Health and Human Services

Class 2 Device Recall Total Ossicular Replacement Prosthesis, CliP Piston MVP

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  Class 2 Device Recall Total Ossicular Replacement Prosthesis, CliP Piston MVP see related information
Date Initiated by Firm April 27, 2011
Date Posted June 30, 2011
Recall Status1 Terminated 3 on November 23, 2011
Recall Number Z-2711-2011
Recall Event ID 58809
Product Classification Replacement, ossicular prosthesis, total - Product Code ETA
Product Kurz, Heinz Kurz Gmb, Medizintecnik, Tuebinger Strasse 3, 7214 Dusslingen, Germany, Surgical Implant, Clip - Piston MVP Titanium, REF: 1006 711, Lot 2 09 13 06.

Product is designed for ossicular replacement to functionally restore the middle ear in cases of pathologic changes of the conductive hearing mechanism.
Code Information Lot 2 09 13 06
Recalling Firm/
Manufacturer		 Heinz Kurz GmbH Medizintechnik
Tuebinger Strasse 3
Dillingen Germany
For Additional Information Contact Aaron Terry
972-719-2615
Manufacturer Reason
for Recall		 Outer package labels product .75 mm longer than actual size.
FDA Determined
Cause 2		 Labeling False and Misleading
Action Kurz Medical, Inc. sent an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" letter dated May 9, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to return unused product for replacement by using an enclosed FedEx label. If the product has been implanted , the letter requests the customers send the date of surgery and size of the implant.
Quantity in Commerce 32, only 8 consigned with U. S. hospitals
Distribution Nationwide Distribution--USA (nationwide) including the states of MN, NC, and WA.
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.
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