Device recall
Z-0087-2011: Manta Ray: Anterior Cervical Plate (ACP) System, 510 (k) #K080690. The labeling…
FDA device recall · Class II · Theken Spine Llc
Key facts
| Recall number (Z-number) | Z-0087-2011 |
|---|---|
| Recall event | 56502 |
| Product | Manta Ray: Anterior Cervical Plate (ACP) System, 510 (k) #K080690. The labeling for the plate component reads in part: 'REF: 22-'**** MAT'L: Titanium per ASTM F-136, Lot: W****, Description: Plate - 40 mm, Qty: 1.' The labeling for the screw component reads in part: 'REF: 22-**** MAT'L: Titanium per… |
| Product code | KWQ |
| Recalling firm | Theken Spine Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 21, 2012 |
| 510(k) numbers | K080690 |
| FEI number | 3002498892 |
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