Stryker Trio Small Offset Connector Non Sterile; Manufactured by Stryker Spine SAS, Z.I. Marticot -33610- Cestas, France
FDA device recall Z-0986-2009 · posted 2009-04-10 · Terminated
Recall details
- Recalling firm
- Stryker Spine
- Reason for recall
- Reports were received of the ball ring ejecting from the connector's body when other connectors have already been locked down.
- Action taken
- 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
- Status
- Terminated
- Product code
- MNI
- Quantity affected
- 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.
- Date initiated
- 2006-09-05
- Date posted
- 2009-04-10
- Date terminated
- 2009-04-14
- 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 |
|---|---|---|
| STRYKER SPINE TRIO SPINAL FIXATION SYSTEM (K052971) | Stryker Spine | 2005-11-16 |