Z-0986-2009

Stryker Trio Small Offset Connector Non Sterile; Manufactured by Stryker Spine SAS, Z.I. Marticot -33610...

Name: Z-0986-2009 Stryker Trio Small Offset Connector Non Sterile; Manufactured by Stryker Spine SAS, Z.I. Marticot -33610...
Creator: Stryker Spine
Published: 2006-09-05
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2006-09-05 / Terminated / root cause: design

FDA source

Stryker Spine began a recall of Stryker Trio Small Offset Connector Non Sterile; Manufactured by Stryker Spine SAS, Z.I. Marticot -33610- Cestas, France. Distributed in USA by Howmedica... on 2006-09-05. The reason FDA records is "Reports were received of the ball ring ejecting from the connector's body when other connectors have already been locked down". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0986-2009
Status: Terminated
Initiated: 2006-09-05
Posted: 2009-04-10
Terminated: 2009-04-14
Recalling firm: Howmedica Osteonics Corp
Product: 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.
Product code: MNI Orthosis, Spinal Pedicle Fixation
Reason for recall: Reports were received of the ball ring ejecting from the connector's body when other connectors have already been locked down.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 2,417 units
Distribution: 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.
Product codes and lots: Catalog Number 48902015; Lot codes: 056254, 056255, 056256, 056257, 56258, 056259, 058065, 05A140, 05A142, 058066, 05A139, 05A141, 058915, 05A143, 05A145, 05A146, 05A144, 061075, 061077, 061551, 061072, 061076, 0615550, 061549, 061760, 05A148, 05A149, and 05A147.

Product code MNI

K052971Class IIStryker Spine Trio Spinal Fixation SystemStryker Spine / cleared 2005-11-16

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)