FDA Medical Device Recalls (openFDA)
Stryker Spine: 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.
- Recall number
- Z-1886-2009
- Recalling firm
- Stryker Spine
- 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.
- Status
- Terminated
- Initiated
- 2009-07-01
- Posted
- 2009-09-16
- Terminated
- 2009-10-20
- Reason
- The Trio 3.5MM Hex socket has been reported to break under high stresses.
- 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
- 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.
- Lot, serial or model codes
- Catalog number 48906075, all lots
- 510(k) numbers
- ["K032855","K052971","K062698"]
- PMA numbers
- not on file
- Product code
- MNH
- Firm FEI
- 3004024955
- Firm city
- Allendale
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28