Synthes InSitu Bender Cutter Kit Narrow Sterile Catalog number 530.522S, used with Synthes Rapid Resorbable Fixation Sys
FDA device recall Z-1249-2009 · posted 2009-06-01 · Terminated
Recall details
- Recalling firm
- Synthes Spine
- Reason for recall
- The bender is heating prior to activation of the power button, requiring disassembly to stop heating.
- Action taken
- All affected Synthes CMF Sales Consultants were notified of the Medical Device Recall by phone on 12/19/08 and by letter sent via return receipt email on 12/22/08. All affected hospitals were notified by letter mailed on 12/22/08 via USPS certified mail.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 40 units
- Distribution
- Nationwide distribution: AL, CA, KS, LA, MD, NJ, NV, NY, OR, PA, TX, and UT
- Date initiated
- 2008-12-18
- Date posted
- 2009-06-01
- Date terminated
- 2009-12-15
- Location
- West Chester, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNTHES IN-SITU BENDER/CUTTER (K021458) | Synthes (Usa) | 2002-07-24 |