Z-0178-2010

Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 48 degrees, sterile...

Name: Z-0178-2010 Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 48 degrees, sterile...
Creator: Zimmer Inc.
Published: 2009-09-17
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-09-17 / Terminated

FDA source

Zimmer Inc. began a recall of Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 48 degrees, sterile, Zimmer, Warsaw, IN, REF 4348-112-13. Shoulder... on 2009-09-17. The reason FDA records is "Some of the devices may possess a taper which will not mate with the humeral head, as intended". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0178-2010
Status: Terminated
Initiated: 2009-09-17
Posted: 2009-11-12
Terminated: 2009-12-22
Recalling firm: Zimmer GmbH
Product: Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 48 degrees, sterile, Zimmer, Warsaw, IN, REF 4348-112-13. Shoulder replacement surgery.
Product code: HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Reason for recall: Some of the devices may possess a taper which will not mate with the humeral head, as intended.
FDA root cause: Other
Action: Zimmer distributors were notified by email on 9/19/09 to locate and return the products. Letter dated 9/29/09 were sent to the Zimmer salesforce and distributors with a letter to be given to each affected hospital account to inform them of the problem. Zimmer accounts were again asked to locate and return the devices. Hospital accounts were requested to consider the available facts when monitoring potentially affected patients.
Quantity in commerce: 12
Distribution: Nationwide.
Product codes and lots: Lot 60947164.

Product code HSD

K041549Class IIZimmer Trabecular Metal Humeral StemZimmer, Inc. / cleared 2004-09-01

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)