Stryker Trio Connector Hex Socket for Torque Wrench 3.5MM Not Sterile: Manufactured by: Stryker Spine SAS, Cestas, Franc
FDA device recall Z-1886-2009 · posted 2009-09-16 · Terminated
Recall details
- Recalling firm
- Stryker Spine
- Reason for recall
- The Trio 3.5MM Hex socket has been reported to break under high stresses.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MNH
- Quantity affected
- 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.
- Date initiated
- 2009-07-01
- Date posted
- 2009-09-16
- Date terminated
- 2009-10-20
- Location
- Allendale, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRIO + SPINAL SYSTEM (K062698) | Stryker Spine | 2006-10-11 |
| STRYKER SPINE TRIO SPINAL FIXATION SYSTEM (K052971) | Stryker Spine | 2005-11-16 |
| STRYKER SPINE MAPS SYSTEM (K032855) | Howmedica Osteonics | 2003-12-10 |