Device recall
Z-1784-2010: Modular Foot System 3.5mm x 22mm Locking Screw M/N: MFT-021-35-22. OrthoHelix…
FDA device recall · Class II · Orthohelix Surgical Designs Inc
Key facts
| Recall number (Z-number) | Z-1784-2010 |
|---|---|
| Recall event | 55256 |
| Product | Modular Foot System 3.5mm x 22mm Locking Screw M/N: MFT-021-35-22. OrthoHelix Surgical Designs, Inc. Medina, OH 44256. Intended as a guide to normal healing and are not intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing. |
| Product code | HWC |
| Recalling firm | Orthohelix Surgical Designs Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 10, 2012 |
| 510(k) numbers | K073624 |
| FEI number | 3000718467 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database