Z-1279-06

Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, 16 mm diameter, 130 mm length, non-sterile...

Name: Z-1279-06 Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, 16 mm diameter, 130 mm length, non-sterile...
Creator: Zimmer Inc.
Published: 2006-06-16
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2006-06-16 / Terminated

FDA source

Zimmer Inc. began a recall of Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, 16 mm diameter, 130 mm length, non-sterile, catalog no. 4309-16-13 (00-4309-016-13) on 2006-06-16. The reason FDA records is "During provisional trialing, the instrument may become stuck in the humeral canal and require surgical removal". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1279-06
Status: Terminated
Initiated: 2006-06-16
Posted: 2006-07-27
Terminated: 2007-12-05
Recalling firm: Zimmer GmbH
Product: Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, 16 mm diameter, 130 mm length, non-sterile, catalog no. 4309-16-13 (00-4309-016-13).
Product code: HWT Template
Reason for recall: During provisional trialing, the instrument may become stuck in the humeral canal and require surgical removal.
FDA root cause: Other
Action: U.S. and international distributors were notified of the recall via letter dated 6/30/2006 to check customer inventories and to return recalled product to the firm. Trial implants were redesigned and reworked to eliminate the problem.
Quantity in commerce: 324 total
Distribution: Nationwide and worldwide including Australia, Canada, Germany, Italy and Spain.
Product codes and lots: All lots.

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)