Z-2711-2011

Kurz, Heinz Kurz Gmb, Medizintecnik, Tuebinger Strasse 3, 7214 Dusslingen, Germany, Surgical Implant, Clip...

Name: Z-2711-2011 Kurz, Heinz Kurz Gmb, Medizintecnik, Tuebinger Strasse 3, 7214 Dusslingen, Germany, Surgical Implant, Clip...
Creator: Heinz Kurz GmbH Medizintechnik
Published: 2011-04-27
License: https://open.fda.gov/license/

Heinz Kurz GmbH Medizintechnik / initiated 2011-04-27 / Terminated / root cause: labeling and UDI

FDA source

Heinz Kurz GmbH Medizintechnik began a recall of Kurz, Heinz Kurz Gmb, Medizintecnik, Tuebinger Strasse 3, 7214 Dusslingen, Germany, Surgical Implant, Clip - Piston MVP Titanium, REF: 1006 711, Lot 2 09 13... on 2011-04-27. The reason FDA records is "Outer package labels product .75 mm longer than actual size". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2711-2011
Status: Terminated
Initiated: 2011-04-27
Posted: 2011-06-30
Terminated: 2011-11-23
Recalling firm: Heinz Kurz GmbH Medizintechnik
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.
Product code: ETA Replacement, Ossicular Prosthesis, Total
Reason for recall: Outer package labels product .75 mm longer than actual size.
Root cause tag: labeling and UDI
FDA 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 in commerce: 32, only 8 consigned with U. S. hospitals
Distribution: Nationwide Distribution--USA (nationwide) including the states of MN, NC, and WA.
Product codes and lots: Lot 2 09 13 06

Product code ETA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)