Z-0210-2007

Zimmer Trabecular metal shoulder instrumentation proximal provisional humeral stem, 48 degrees, 9/10 mm...

Name: Z-0210-2007 Zimmer Trabecular metal shoulder instrumentation proximal provisional humeral stem, 48 degrees, 9/10 mm...
Creator: Zimmer Inc.
Published: 2006-10-19
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2006-10-19 / Terminated

FDA source

Zimmer Inc. began a recall of Zimmer Trabecular metal shoulder instrumentation proximal provisional humeral stem, 48 degrees, 9/10 mm diameter, nonsterile; REF 4309-18-10, Catalog no... on 2006-10-19. The reason FDA records is "The instrument may fracture at the threaded end during intramedullary trialing and leave the distal pilot trial in the humeral canal". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0210-2007
Status: Terminated
Initiated: 2006-10-19
Posted: 2006-11-22
Terminated: 2007-12-05
Recalling firm: Zimmer GmbH
Product: Zimmer Trabecular metal shoulder instrumentation proximal provisional humeral stem, 48 degrees, 9/10 mm diameter, nonsterile; REF 4309-18-10, Catalog no. 00-4309-018-10.
Product code: HWT Template
Reason for recall: The instrument may fracture at the threaded end during intramedullary trialing and leave the distal pilot trial in the humeral canal.
FDA root cause: Other
Action: The firm''s sales force was notified via recall letter dated 10/19/06 to secure product from customer accounts and to return it to Zimmer.
Quantity in commerce: 50
Distribution: Nationwide and Australia.
Product codes and lots: Lots 60457716 and 60492624.

Product code HWT

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 2026-09-05. View this recall on fda.gov (opens on fda.gov)