Device recall
Z-2138-2011: SharpointTM 4-0 Black Monofilament Non-Absorbable Nylon 18"/DS24mm Reverse…
FDA device recall · Class III · Surgical Specialties Corp
Key facts
| Recall number (Z-number) | Z-2138-2011 |
|---|---|
| Recall event | 58449 |
| Product | SharpointTM 4-0 Black Monofilament Non-Absorbable Nylon 18"/DS24mm Reverse Cutting Edged Needle. Intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, opthalmic, and neurological procedures. |
| Product code | DTH |
| Recalling firm | Surgical Specialties Corp |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 4, 2011 |
| 510(k) numbers | K903029 |
| FEI number | 2522801 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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