Z-1004-04

M/DN Intramedullary Fixation Humeral Nail

Name: Z-1004-04 M/DN Intramedullary Fixation Humeral Nail
Creator: Zimmer Inc.
Published: 2004-03-16
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2004-03-16 / Terminated

FDA source

Zimmer Inc. began a recall of M/DN Intramedullary Fixation Humeral Nail on 2004-03-16. The reason FDA records is "One and possibly more units in the lot have the proximal angled hole oriented 180 degrees reversed from the required orientation". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1004-04
Status: Terminated
Initiated: 2004-03-16
Posted: 2004-07-20
Terminated: 2004-07-02
Recalling firm: Zimmer GmbH
Product: M/DN Intramedullary Fixation Humeral Nail
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: One and possibly more units in the lot have the proximal angled hole oriented 180 degrees reversed from the required orientation.
FDA root cause: Other
Action: Units were distributed to twelve (12) consignees in the US and seven (7) foreign consignees (China, Japan, Korea, El Salvador, Singapore, Taiwan and UK)
Quantity in commerce: 33 units
Product codes and lots: Catalog no. 00-2254-195-09 Lot # 20118000

Product code HSB

K965098Class IIIntramedullary Nail SystemZimmer, Inc. / cleared 1997-02-28

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)