Z-0126-04

Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 5 3/4 inches in length...

Name: Z-0126-04 Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 5 3/4 inches in length...
Creator: Zimmer Inc
Published: 2003-10-15
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2003-10-15 / Terminated

FDA source

Zimmer Inc began a recall of Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 5 3/4 inches in length. Catalog # 281-01-14 on 2003-10-15. The reason FDA records is "The pin may fail because the metal used to make the pin does not meet the firm's hardness specification". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0126-04
Status: Terminated
Initiated: 2003-10-15
Posted: 2004-07-20
Terminated: 2004-05-20
Recalling firm: Zimmer GmbH
Product: Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 5 3/4 inches in length. Catalog # 281-01-14.
Product code: JDW Pin, Fixation, Threaded
Reason for recall: The pin may fail because the metal used to make the pin does not meet the firm's hardness specification.
FDA root cause: Other
Action: All affected U.S. accounts were sent a letter dated October 15, 2003 by certified mail, return receipt requested. The seven foreign initial consignee accounts were notified via electronic mail. Customers were asked to return non-implanted product and to advise the implanting surgeons of the problem so that they may take appropriate action in regard to their patients.
Distribution: The majority of the pins were distributed within the United States. Distribution also occured in seven foreign countries; Taiwan, Canada, Japan, Korea, Belgium, Australia and Finland.
Product codes and lots: Lot 54008400.

Product code JDW

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)