Recall Z-2711-2011
Heinz Kurz GmbH Medizintechnik · initiated April 27, 2011
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.
Codes / lots: Lot 2 09 13 06
Reason for recall
Outer package labels product .75 mm longer than actual size.
FDA-determined cause: Labeling False and Misleading
Action taken
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.
Details
- Recall number
- Z-2711-2011
- Initiated
- April 27, 2011
- Posted by FDA
- June 30, 2011
- Terminated
- November 23, 2011
- Product code
- ETA – Replacement, Ossicular Prosthesis, Total
- Quantity
- 32, only 8 consigned with U. S. hospitals
- Distribution
- Nationwide Distribution--USA (nationwide) including the states of MN, NC, and WA.
- Recalling firm
- Heinz Kurz GmbH Medizintechnik, Dillingen