Z-0796-2010

Depth Gauge; Catalog Number: 703707; Stryker Trauma AG, CH 2545 Selzach; Distributed in USA by Howmedica...

Name: Z-0796-2010 Depth Gauge; Catalog Number: 703707; Stryker Trauma AG, CH 2545 Selzach; Distributed in USA by Howmedica...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2009-12-22
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2009-12-22 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Depth Gauge; Catalog Number: 703707; Stryker Trauma AG, CH 2545 Selzach; Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ... on 2009-12-22. The reason FDA records is "The Depth Measuring Gauges have 5 scale marking instead of the required 4 scale markings". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0796-2010
Status: Terminated
Initiated: 2009-12-22
Posted: 2010-02-19
Terminated: 2010-03-16
Recalling firm: Howmedica Osteonics Corp
Product: Depth Gauge; Catalog Number: 703707; Stryker Trauma AG, CH 2545 Selzach; Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. This product is sold separately or as part of Kit # 990256. The depth gauge is an instrument in the VariAx Elbow System. Depth gauges are tools used intra-operatively, to aid in correct screw selection. They can be used with a plate, or directly on bone.
Product code: HTJ Gauge, Depth
Reason for recall: The Depth Measuring Gauges have 5 scale marking instead of the required 4 scale markings.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Urgent Product Recall letters, dated December 22, 2009, were sent to all Stryker Branches/Agencies. Letters were also sent to hospitals and surgeons that use the VariaAx Elbow System were also notified. All letters were sent by Federal Express. The letters identified the affected product, stated the issue, and the hazards involved. It also asked customers to examine their inventory and hospital locations to identify affected products. All affected products are to be retrieved and returned to their branch or agency warehouse for reconciliation. All products should be reconciled on the attached Product Accountability Form and a copy should be faxed to 201-831-6069 within 5 days of receipt of the notice. Follow the instructions for shipping the affected product back to the firm. Questions should be directed to 201-972-2100.
Quantity in commerce: 49
Distribution: Nationwide Distribution
Product codes and lots: Lot code: U09984 VariaAx Elbow System Instrument Set - kitted, material transaction lots # U23151, U24021, U25906 and U29985 all contain one piece of the affected recalled catalog number.

Product code HTJ

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)