Device recall
Z-2658-2017: 3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01…
FDA device recall · Class II · Encore Medical, Lp
Key facts
| Recall number (Z-number) | Z-2658-2017 |
|---|---|
| Recall event | 77435 |
| Product | 3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01, The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695… |
| Product code | JWH |
| Recalling firm | Encore Medical, Lp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 8, 2021 |
| 510(k) numbers | K091956 |
| FEI number | 1000116912 |
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