Device recall
Z-0251-04: PROLENE* Mesh, Polypropylene Non Absorbable Synthetic Surgical Mesh, PMII…
FDA device recall · Class II · Owens & Minor Distribution, Inc.
Key facts
| Recall number (Z-number) | Z-0251-04 |
|---|---|
| Recall event | 27656 |
| Product | PROLENE* Mesh, Polypropylene Non Absorbable Synthetic Surgical Mesh, PMII, 3''x6'', each mesh in a sealed pouch package, 6 packages per papercard carton. Cartons labeled in part ***ETHICON, INC., a Johnson & Johnson company SOMERVILLE, NEW JERSEY 08876-0151 ***STERILE: Sterility of contents… |
| Product code | FTL |
| Recalling firm | Owens & Minor Distribution, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 4, 2011 |
| FEI number | 3003753847 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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