Z-1285-03

Stanmore modular hip system; Stanmore CoCr femoral size 5 std. stem; part 164245

Name: Z-1285-03 Stanmore modular hip system; Stanmore CoCr femoral size 5 std. stem; part 164245
Creator: Biomet, Inc.
Published: 2003-06-18
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2003-06-18 / Terminated / root cause: labeling and UDI

FDA source

Biomet, Inc. began a recall of Stanmore modular hip system; Stanmore CoCr femoral size 5 std. stem; part 164245 on 2003-06-18. The reason FDA records is "The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1285-03
Status: Terminated
Initiated: 2003-06-18
Posted: 2003-09-24
Terminated: 2003-09-23
Recalling firm: Zimmer GmbH
Product: Stanmore modular hip system; Stanmore CoCr femoral size 5 std. stem; part 164245
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Distributors were sent a letter on June 18, 2003 via FedEx. This mailing contained labels and the distributors were instructed to affix the label to the inventory consigned to hospitals within their territory.
Quantity in commerce: 30
Distribution: United States
Product codes and lots: lots 197284, 211992, 211998, 225646, 226431, 233479, 233677, 251871, 255929, 266786, 269741, 279430, 286358, 292600, 292735, 326453, 336746

Product code JDI

K911684Class IIBiomet Cobalt-Chrome Femoral ComponentsBiomet, Inc. / cleared 1991-06-27

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)