Recall Z-2711-2011 ยท ETA Replacement, Ossicular Prosthesis, Total
Heinz Kurz GmbH Medizintechnik
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.
| Date | Jun 30, 2011 (initiated Apr 27, 2011) |
| Status | Terminated |
| Reason | Outer package labels product .75 mm longer than actual size. |
| Root cause | 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 | 32, only 8 consigned with U. S. hospitals |
| Distribution | Nationwide Distribution--USA (nationwide) including the states of MN, NC, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.