MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY. Product Usage: Variable Angle technology in MTP
FDA device recall Z-0421-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Orthohelix Surgical Designs Inc
- Reason for recall
- The firm discovered a testing protocol error, in both dynamic and static cantilever comparative testing, during the initial comparative testing.
- Action taken
- Orthohelix Surgical Designs Inc. sent an URGENT RECALL NOTIFICATION letter dated August 22, 2011 to all affected customers. The letter identified the affected products, the problem, and the actions to be taken. Customers were instructed to immediately inventory, remove and return the recalled product to the firm via FedEx or any shipping method with tracking capability. Customers were also requested to notify any affected user facilities of the recall. For any questions call 330-247-1444 or 330-247-1445.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 2,722 units
- Distribution
- Nationwide Distribution (USA) - including the states of: CA, CO, CT, FL, GA, IA, IL, KY, LA, MD, MI, MO, NC, NJ, NM, NY, OH, OK, PA, SD, TN, TX, UT, VA, WA, WI and WY.
- Date initiated
- 2011-08-22
- Date posted
- 2012-01-11
- Date terminated
- 2012-02-19
- Location
- Medina, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWS (K102156) | Orthohelix Surgical Designs, Inc. | 2010-09-30 |