Z-1554-05

The TRIO Spondylolisthesis Reduction Instrument is a Class I Manual Surgical Instrument unique to the...

Name: Z-1554-05 The TRIO Spondylolisthesis Reduction Instrument is a Class I Manual Surgical Instrument unique to the...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2005-05-16
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2005-05-16 / Terminated

FDA source

Stryker Howmedica Osteonics Corp. began a recall of The TRIO Spondylolisthesis Reduction Instrument is a Class I Manual Surgical Instrument unique to the implantation of Stryker Spine TRIO PS this instrument is... on 2005-05-16. The reason FDA records is "The threaded part of the instrument may break when connected to the screw and potentially result in an adverse health consequence". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1554-05
Status: Terminated
Initiated: 2005-05-16
Posted: 2005-09-21
Terminated: 2005-12-02
Recalling firm: Howmedica Osteonics Corp
Product: 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.
Product code: MNH Orthosis, Spondylolisthesis Spinal Fixation
Reason for recall: The threaded part of the instrument may break when connected to the screw and potentially result in an adverse health consequence.
FDA root cause: Other
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.
Quantity in commerce: 107
Distribution: 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.
Product codes and lots: Catalog No: 48905110 Lot Code: 039524; 039981; 045152; 045153; 045154; 045155; 045156; 045157; 045158; 045159; 048721; 048722.

Product code MNH

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)