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.
FDA Recall Z-2711-2011 · Posted 2011-06-30
Recalling FirmHeinz Kurz GmbH Medizintechnik
Recall StatusTerminated
Product CodeETA
Date Initiated2011-04-27
Date Terminated2011-11-23
Product Quantity32, only 8 consigned with U. S. hospitals
Reason for Recall
Outer package labels product .75 mm longer than actual size.
Firm 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.
Root Cause
Labeling False and Misleading
Distribution Pattern
Nationwide Distribution--USA (nationwide) including the states of MN, NC, and WA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.