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.
This recall has been terminated (originally issued June 30, 2011).
- Recall Initiated
- April 27, 2011
- Posted
- June 30, 2011
- Terminated
- November 23, 2011
- Recall Number
- Z-2711-2011
- Quantity
- 32, only 8 consigned with U. S. hospitals
- Official Source
- View on FDA website ↗
Reason for Recall
Outer package labels product .75 mm longer than actual size.
Distribution
Nationwide Distribution--USA (nationwide) including the states of MN, NC, and WA.
Lot / Code Info
Lot 2 09 13 06
Root 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.