Stryker Trio Small Offset Connector Non Sterile; Manufactured by Stryker Spine SAS, Z.I. Marticot -33610- Cestas, France. Distributed in USA by Howmedica Osteonics Corp., Mahwah, NJ. The Trio Spinal Fixation Systems are pedicle screws systems intended for use in providing immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic lumbar, and sacral spine: degenerative spondyolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion.
FDA Recall Z-0986-2009 · Posted 2009-04-10
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Recalling FirmStryker Spine
Recall StatusTerminated
Product CodeMNI
Date Initiated2006-09-05
Date Terminated2009-04-14
Product Quantity2,417 units
Reason for Recall
Reports were received of the ball ring ejecting from the connector's body when other connectors have already been locked down.
Firm Action
A notification letter dated September 12, 2006 and a Product Accountability Form were sent via Federal Express (with return receipt) to all affected branches/agencies.
Further information can be found by calling 1-201-760-8256.
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution including OR, CA, MA, VA, GA, FL, NY, NM, NJ, UT, KS, OH, MI, MN, IN, MT, TX, WI, AL, CO, and TN.
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.
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