—#39387

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.

FDA product code: MNH — Orthosis, Spondylolisthesis Spinal Fixation
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: Catalog No: 48905110 Lot Code: 039524; 039981; 045152; 045153; 045154; 045155; 045156; 045157; 045158; 045159; 048721; 048722.

Why it was recalled

The threaded part of the instrument may break when connected to the screw and potentially result in an adverse health consequence.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2002

Distribution

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.

Timeline

Recall initiated: 2005-05-16
Posted by FDA: 2005-09-21
Terminated: 2005-12-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #39387. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.