Z-0389-05

Zimmer™ Orthopaedic Surgical Products, Disposable Cuff, 12'' (30cm), Single Port, Single Bladder Sterile...

Name: Z-0389-05 Zimmer™ Orthopaedic Surgical Products, Disposable Cuff, 12'' (30cm), Single Port, Single Bladder Sterile...
Creator: Zimmer Orthopaedic Surgical Products
Published: 2004-10-27
License: https://open.fda.gov/license/

Zimmer Surgical SA / initiated 2004-10-27 / Terminated

FDA source

Zimmer Orthopaedic Surgical Products began a recall of Zimmer™ Orthopaedic Surgical Products, Disposable Cuff, 12'' (30cm), Single Port, Single Bladder Sterile, Zimmer, Dover, OH USA. The cuff is a sterile, single... on 2004-10-27. The reason FDA records is "The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0389-05
Status: Terminated
Initiated: 2004-10-27
Posted: 2005-01-12
Terminated: 2005-12-20
Recalling firm: Zimmer Surgical SA
Product: Zimmer™ Orthopaedic Surgical Products, Disposable Cuff, 12'' (30cm), Single Port, Single Bladder Sterile, Zimmer, Dover, OH USA. The cuff is a sterile, single use product equipped with an integral fill line. The product is packed 10 cuffs per unit
Product code: KCY Tourniquet, Pneumatic
Reason for recall: The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release.
FDA root cause: Other
Action: Consignees were first notified via certified mail on 10/27/2004. A follow up letter with 2 addtional lots were sent 11/11/2004.
Quantity in commerce: 42 units (10 cuffs per unit)
Distribution: Nationwide, Australia, Demark, Germany
Product codes and lots: Cat #60-7075-002-00, Lot #60153745

Product code KCY

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 2026-09-06. View this recall on fda.gov (opens on fda.gov)