Device recall
Z-1287-2015: Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific…
FDA device recall · Class II · Materialise N.V.
Key facts
| Recall number (Z-number) | Z-1287-2015 |
|---|---|
| Recall event | 70664 |
| Product | Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended to be used as part of the Signature Personalized Patient Care System. Lt is intended to be used as a guide during the surgical procedure for total and partial knee arthroplasty. |
| Product code | JWH |
| Recalling firm | Materialise N.V. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 30, 2015 |
| 510(k) numbers | K102795 |
| FEI number | 3003998208 |
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