Device recall
Z-1145-2012: REF 42-422561 SIGNATURE QTY, 1 TKA GDE/MDL (Prosthesis, knee) SET 04-05…
FDA device recall · Class II · Biomet, Inc.
Key facts
| Recall number (Z-number) | Z-1145-2012 |
|---|---|
| Recall event | 59740 |
| Product | REF 42-422561 SIGNATURE QTY, 1 TKA GDE/MDL (Prosthesis, knee) SET 04-05 DGHUMPHR-NOV52LKA-J_K-00432022 SLIDEX DISTAL-MP/PREMIER TIBIAL CUSTOM-MADE DEVICE Signature Personalized Patient Care System is intended to be used as a surgical instrument to assist in the positioning of total and partial knee… |
| Product code | JWH |
| Recalling firm | Biomet, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 6, 2012 |
| 510(k) numbers | K102795 |
| FEI number | 1825034 |
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