Device recall
Z-1091-2015: MEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR Implants in…
FDA device recall · Class II · Stryker Craniomaxillofacial Division
Key facts
| Recall number (Z-number) | Z-1091-2015 |
|---|---|
| Recall event | 70166 |
| Product | MEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER Implants… |
| Product code | FWP |
| Recalling firm | Stryker Craniomaxillofacial Division |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 6, 2015 |
| 510(k) numbers | K952677 |
| FEI number | 3005101424 |
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