Z-1886-2009

Stryker Trio Connector Hex Socket for Torque Wrench 3.5MM Not Sterile: Manufactured by: Stryker Spine SAS...

Name: Z-1886-2009 Stryker Trio Connector Hex Socket for Torque Wrench 3.5MM Not Sterile: Manufactured by: Stryker Spine SAS...
Creator: Stryker Spine
Published: 2009-07-01
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2009-07-01 / Terminated

FDA source

Stryker Spine began a recall of Stryker Trio Connector Hex Socket for Torque Wrench 3.5MM Not Sterile: Manufactured by: Stryker Spine SAS, Cestas, France; Distributed in the USA by: Stryker... on 2009-07-01. The reason FDA records is "The Trio 3.5MM Hex socket has been reported to break under high stresses". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1886-2009
Status: Terminated
Initiated: 2009-07-01
Posted: 2009-09-16
Terminated: 2009-10-20
Recalling firm: Howmedica Osteonics Corp
Product: Stryker Trio Connector Hex Socket for Torque Wrench 3.5MM Not Sterile: Manufactured by: Stryker Spine SAS, Cestas, France; Distributed in the USA by: Stryker Spine, Allendale, NJ 07401 The Trio 3.5MM Hex Socket is a reusable instrument, sterilized prior to use, used with the Trio Torque Wrench to facilitate final tightening of Trio connectors and 3.5MM Hex Screw Assembly. This Trio 3.5MM Hex Socket is used with the Trio implant system for posterior noncervical pedical and non pedical fixation of the spine.
Product code: MNH Orthosis, Spondylolisthesis Spinal Fixation
Reason for recall: The Trio 3.5MM Hex socket has been reported to break under high stresses.
FDA root cause: Other
Action: Product Correction letters were sent on July 1, 2009 to all Branches/Agencies, Surgeons and Hospital Risk Management OR Supervisor by Federal Express. The letter indicates the potential hazards associated with the breakage and it reinforces the appropriate surgical technique in using the hex socket. Customers are requested to complete an acknowledgement form and return it via FAX to Aminah Crawford at 201.760.8370 within five (5) days of receipt of the notice. If you have questions, please contact Tiffani Rogers, Regulatory Compliance Manager at 201.760.8206.
Quantity in commerce: 143
Distribution: Nationwide - OR, AR, CA, MA, KY, MD, GA, FL, NY, NM, UT, FL, OK, KS, MI, MN, IN, MT, TX, WI, and TN.
Product codes and lots: Catalog number 48906075, all lots

Product code MNH

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)