Z-0994-04

T2 Proximal Humeral System Targeting Arm. Catalog number 1806-2035

Name: Z-0994-04 T2 Proximal Humeral System Targeting Arm. Catalog number 1806-2035
Creator: Howmedica Osteonics Corp.
Published: 2004-03-31
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2004-03-31 / Terminated

FDA source

Howmedica Osteonics Corp. began a recall of T2 Proximal Humeral System Targeting Arm. Catalog number 1806-2035 on 2004-03-31. The reason FDA records is "Targeting device may become distorted upon repeated autoclaving". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0994-04
Status: Terminated
Initiated: 2004-03-31
Posted: 2004-07-20
Terminated: 2004-06-03
Recalling firm: Howmedica Osteonics Corp
Product: T2 Proximal Humeral System Targeting Arm. Catalog number 1806-2035.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Targeting device may become distorted upon repeated autoclaving.
FDA root cause: Other
Action: On March 31, 2004 recall letters and product accountability forms were sent via FedEx.
Quantity in commerce: 32 devices
Distribution: There were 19 consignees which are Stryker sales representatives and subsidiaries nationwide.
Product codes and lots: Lot Code: K589039; K658262; K658259; K74990; K766542.

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)