FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2711-2011
- 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.
- Status
- Terminated
- Initiated
- 2011-04-27
- Posted
- 2011-06-30
- Terminated
- 2011-11-23
- 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.
- Lot, serial or model codes
- Lot 2 09 13 06
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ETA
- Firm FEI
- 6062
- Firm city
- Dillingen
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28