Z-0719-04

Restoration Hip system Cylindrical Distal Extension. Catalog Numbers 1212-3105, 1212-3115, 1212-3125, and...

Name: Z-0719-04 Restoration Hip system Cylindrical Distal Extension. Catalog Numbers 1212-3105, 1212-3115, 1212-3125, and...
Creator: Stryker Howmedica Osteonics
Published: 2004-02-10
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2004-02-10 / Terminated / root cause: packaging

FDA source

Stryker Howmedica Osteonics began a recall of Restoration Hip system Cylindrical Distal Extension. Catalog Numbers 1212-3105, 1212-3115, 1212-3125, and 1212-3195. Sizes 12.5mm, 11.5mm, 19.5mm, and 10.5mm... on 2004-02-10. The reason FDA records is "The Cylindrical Distal Extensions were incorrectly coded and packaged". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0719-04
Status: Terminated
Initiated: 2004-02-10
Posted: 2004-07-20
Terminated: 2004-06-09
Recalling firm: Howmedica Osteonics Corp
Product: Restoration Hip system Cylindrical Distal Extension. Catalog Numbers 1212-3105, 1212-3115, 1212-3125, and 1212-3195. Sizes 12.5mm, 11.5mm, 19.5mm, and 10.5mm extensions.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The Cylindrical Distal Extensions were incorrectly coded and packaged.
Root cause tag: packaging
FDA root cause: Other
Action: Stryker Orthopaedics sent product recall letters to the Branch/Agency involved on 2/10/2004 via FedEx. International distributor was sent notification on 2/10/2004.
Quantity in commerce: 20
Distribution: The 9 units were sent out to 2 US branch/agents and one international distributor.
Product codes and lots: Lots: 96910501; 96949401; 96940901; 96950901.

Product code LXH

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)