Z-0034-06

Stryker brand Intra-Compartmental (STIC) Pressure Monitor, Model 295-001-000

Name: Z-0034-06 Stryker brand Intra-Compartmental (STIC) Pressure Monitor, Model 295-001-000
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2005-07-22
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2005-07-22 / Terminated

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Stryker brand Intra-Compartmental (STIC) Pressure Monitor, Model 295-001-000 on 2005-07-22. The reason FDA records is "The pressure indicated may be inaccurate, and this inaccuracy may be not detectable by the user". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0034-06
Status: Terminated
Initiated: 2005-07-22
Posted: 2005-10-12
Terminated: 2006-02-15
Recalling firm: Stryker Corp.
Product: Stryker brand Intra-Compartmental (STIC) Pressure Monitor, Model 295-001-000.
Product code: LXC Monitor, Pressure, Intracompartmental
Reason for recall: The pressure indicated may be inaccurate, and this inaccuracy may be not detectable by the user.
FDA root cause: Other
Action: Consignees were notified by recall letter dated August 5, 2005 to locate the affected serial numbers and to return the product to the firm.
Quantity in commerce: 473
Distribution: Nationwide, Argentina, Australia, Canada, Costa Rica, England, France, Germany, Hong Kong, India, Indonesia, Japan, Netherlands, New Zealand, South Africa, Spain, Sweden, Switzerland, Taipei, Turkey and United Arab Emir.
Product codes and lots: Serial numbers 0428702183 through 0518008193.

Product code LXC

K844214UnclassifiedCompartment Syndrome Pressure Monitor SysStryker Corp. / cleared 1985-04-04

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)