MaxTorque Cannulated Screw Model # MSD-010-55-060S
FDA device recall Z-1250-2010 · posted 2010-04-06 · Terminated
Recall details
- Recalling firm
- Orthohelix Surgical Designs Inc
- Reason for recall
- A pinhead sized disc was found in the cannulation of a MSD-010-55-60S screw.
- Action taken
- On April 7, 2009 the firm sent letters to their customers with detailed instructions on how to correct the problem. Pictures were included for clarification. For questions please contact either Jim Bragg via phone at 330-869-9562 ext 211 or Kristin Wolff at ext 209.
- Root cause
- Other
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 45 pieces
- Distribution
- Product was delivered to: CA, CO, GA, NM, NY, OH, VA & WA.
- Date initiated
- 2009-04-07
- Date posted
- 2010-04-06
- Date terminated
- 2010-10-20
- Location
- Medina, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CSS CANNULATED SCREW SYSTEM (K060428) | Orthohelix Surgical Designs, Inc. | 2006-03-07 |