The Instructions For Use for the following: Stryker TRIO+ 4.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 50 mm STAN
FDA device recall Z-2235-2012 · posted 2012-08-22 · Terminated
Recall details
- Recalling firm
- Stryker Spine
- Reason for recall
- The front cover of Instructions For Use (IFU) #NOLI135B03Rev02 was improperly marked with a "Sterile" logo in the lower right corner. The products these IFUs were packed with are sold as "Non-Sterile" and require sterilization before use in surgery.
- Action taken
- Stryker sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter to affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Customer Response Form was attached for customers to complete and return via fax to 201-760-8370. Contact the firm at 201-760-8298 for questions regarding this notice.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- MNI
- Quantity affected
- 40 units.
- Distribution
- Distributed in Atlanta, Georgia.
- Date initiated
- 2012-04-25
- Date posted
- 2012-08-22
- Date terminated
- 2013-02-27
- 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 |