Z-0792-2010

Stryker Xia Precision System; Jam Shidi 13 Gauge 5 inch; Sterile; Manufactured for: Stryker Spine SAS...

Name: Z-0792-2010 Stryker Xia Precision System; Jam Shidi 13 Gauge 5 inch; Sterile; Manufactured for: Stryker Spine SAS...
Creator: Stryker Spine
Published: 2010-01-18
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2010-01-18 / Terminated / root cause: packaging

FDA source

Stryker Spine began a recall of Stryker Xia Precision System; Jam Shidi 13 Gauge 5 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica... on 2010-01-18. The reason FDA records is "Stryker Spine received reports of packaging failures during shipping for the Jam Shidi instruments, which may compromise the sterility of the product". 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-0792-2010
Status: Terminated
Initiated: 2010-01-18
Posted: 2010-02-16
Terminated: 2012-09-06
Recalling firm: Howmedica Osteonics Corp
Product: Stryker Xia Precision System; Jam Shidi 13 Gauge 5 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ. Intended for use as a manual surgical instrument during percutaneous posterior, non-cervical pedicle fixation.
Product code: LHX Trousers, Anti-Shock
Reason for recall: Stryker Spine received reports of packaging failures during shipping for the Jam Shidi instruments, which may compromise the sterility of the product.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Stryker Spine issued an "Urgent Product Recall" notification dated January 15, 2010 via Federal Express to all consignees. The letter informed users of the issue and potential hazards of the affected product. For further information, contact your local Stryker Spine Sales Representative or call 201-760-8206.
Quantity in commerce: 2717 total, all sizes.
Distribution: Nationwide distribution.
Product codes and lots: Catalog number: 48237135; all lots.

Product code LHX

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)