Z-1702-2009

Zimmer ITST Intertrochanteric/subtrochanteric fixation taper reamer - Asia, nonsterile; REF 2258-50-01...

Name: Z-1702-2009 Zimmer ITST Intertrochanteric/subtrochanteric fixation taper reamer - Asia, nonsterile; REF 2258-50-01...
Creator: Zimmer Inc.
Published: 2009-06-05
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-06-05 / Terminated / root cause: manufacturing process

FDA source

Zimmer Inc. began a recall of Zimmer ITST Intertrochanteric/subtrochanteric fixation taper reamer - Asia, nonsterile; REF 2258-50-01. (Note: This product is not distributed in the United... on 2009-06-05. The reason FDA records is "Reamers labeled as having a standard diameter may actually be the dimensions of an Asia reamer, and vice versa". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1702-2009
Status: Terminated
Initiated: 2009-06-05
Posted: 2009-08-04
Terminated: 2009-12-22
Recalling firm: Zimmer GmbH
Product: Zimmer ITST Intertrochanteric/subtrochanteric fixation taper reamer - Asia, nonsterile; REF 2258-50-01. (Note: This product is not distributed in the United States).
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Reamers labeled as having a standard diameter may actually be the dimensions of an Asia reamer, and vice versa.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Zimmer sent an Urgent Device Recall letter dated 6/5/09 to all consignees and instructed to locate and return the products.
Quantity in commerce: 120 of both products
Distribution: Worldwide distribution: USA, China, Germany, Japan, Korea and Thailand.
Product codes and lots: Lots 60639048 and 60657449.

Product code HSB

K032367Class IIItst Intertrochanteric Subtrochanteric Intramedullary Femoral NailZimmer, Inc. / cleared 2003-08-12

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)