Z-1261-2009

Zimmer Sirus Intramedullary nail for tibia, cannulated, diameter 12 L, 330 mm, sterile, Zimmer GmbH...

Name: Z-1261-2009 Zimmer Sirus Intramedullary nail for tibia, cannulated, diameter 12 L, 330 mm, sterile, Zimmer GmbH...
Creator: Zimmer Inc.
Published: 2009-03-23
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-03-23 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Inc. began a recall of Zimmer Sirus Intramedullary nail for tibia, cannulated, diameter 12 L, 330 mm, sterile, Zimmer GmbH, Winterthur, Switzerland; REF 02.02631.233. The device is... on 2009-03-23. The reason FDA records is "The package is labeled as containing 330 mm length nails, but actually contains 300 mm length nails". 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-1261-2009
Status: Terminated
Initiated: 2009-03-23
Posted: 2009-05-18
Terminated: 2009-10-23
Recalling firm: Zimmer GmbH
Product: Zimmer Sirus Intramedullary nail for tibia, cannulated, diameter 12 L, 330 mm, sterile, Zimmer GmbH, Winterthur, Switzerland; REF 02.02631.233. The device is used in orthopedic trauma surgeries for stabilization of tibial bone fractures.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: The package is labeled as containing 330 mm length nails, but actually contains 300 mm length nails.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Distributors were initially notified by phone on March 23, 2009. Distributors and user accounts were notified by an "Urgent: Device Recall" letter dated March 31, 2009. The letter described the affected product, reason for recall, risks to health, other information and actions for customers. Customers were instructed to quarantine recalled product and to return it to the Zimmer Distribution Center. For questions about the recall, contact Zimmer, Inc. at 1-800-613-6131.
Quantity in commerce: 32
Distribution: Worldwide Distribution -- US (states of Florida, Missouri, New Jersey, New York, Ohio, Oklahoma and Texas) and countries of Austria, Japan, Korea and Germany.
Product codes and lots: Lot Number 2385866.

Product code HSB

K043270Class IISirus Intramedullary Nail-Femoral and Tibial Nails, Models 02.02631, 02.02651, 02.02652 SeriesZimmer GmbH / cleared 2005-01-31

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)