Device recall
Z-2135-2008: Smooth or threaded metallic bone fixation fastener. 3.5mm x 14.0 mm Locking…
FDA device recall · Class III · Acumed LLC
Key facts
| Recall number (Z-number) | Z-2135-2008 |
|---|---|
| Recall event | 48457 |
| Product | Smooth or threaded metallic bone fixation fastener. 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled in 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled in part, "Congruent Plate System... Size: 3.5mm x 14.0 mm Locking Cortical Screw... REF COL-3140-S LOT W46772... Acumed 5885 NW… |
| Product code | HWC |
| Recalling firm | Acumed LLC |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 3, 2010 |
| 510(k) numbers | K012655, K942340, K942341 |
| FEI number | 1000125930 |
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