Stryker brand Intra-Compartmental (STIC) Pressure Monitor, Model 295-001-000.
FDA Recall Z-0034-06 · Posted 2005-10-12
Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeLXC
Date Initiated2005-07-22
Date Terminated2006-02-15
Product Quantity473
Reason for Recall
The pressure indicated may be inaccurate, and this inaccuracy may be not detectable by the user.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.