Device recall
Z-1016-2007: Suture Diameter/Strength specification failure: Various Polydioxanone Absorbable…
FDA device recall · Class II · Teleflex Creek Dr
Key facts
| Recall number (Z-number) | Z-1016-2007 |
|---|---|
| Recall event | 38220 |
| Product | Suture Diameter/Strength specification failure: Various Polydioxanone Absorbable Surgical Sutures-NDR, MDK VI MF 0 TC43/HR2648, Catalog #833-137, Monodek, MDK VI MF 2-0 FS-1 1N27, Catalog # M451V |
| Product code | GAM |
| Recalling firm | Teleflex Creek Dr |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 14, 2008 |
| 510(k) numbers | K030212 |
| FEI number | 3005747797 |
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