The TRIO Spondylolisthesis Reduction Instrument is a Class I Manual Surgical Instrument unique to the implantation of Stryker Spine TRIO PS this instrument is intended for use in the reduction of degenerative Spondylolisthesis.
FDA Recall Z-1554-05 · Posted 2005-09-21
Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeMNH
Date Initiated2005-05-16
Date Terminated2005-12-02
Product Quantity107
Reason for Recall
The threaded part of the instrument may break when connected to the screw and potentially result in an adverse health consequence.
Firm Action
The notification letters and product accountability forms were sent to their branches/agencies and the one hospital via Fedex on 5/16/2005 with return receipt.
Root Cause
Other
Distribution Pattern
Stryker distributes their product though branches/agencies and occassionally directly to hospitals. These branches/agencies are located nationwide and will deliver the device to the medical facility. There are 31 branches and 1 hospital involved.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.