Device recall
Z-1351-2021: NUVASIVE FREEDOM: End Cap for PRECICE Intramedullary Limb Lengthening System…
FDA device recall · Class II · Nuvasive Specialized Orthopedics Inc
Key facts
| Recall number (Z-number) | Z-1351-2021 |
|---|---|
| Recall event | 87353 |
| Product | NUVASIVE FREEDOM: End Cap for PRECICE Intramedullary Limb Lengthening System Implant; Packaged End Cap 8.5/10.7mm, +0mm; Packaged End Cap 8.5/10.7mm, +5mm; Packaged End Cap 8.5/10.7mm, +10mm; Packaged End Cap 8.5/10.7mm, +15mm; Packaged End Cap 8.5/10.7mm, +20mm; Packaged End Cap 12.5mm, +0mm… |
| Product code | HSB |
| Recalling firm | Nuvasive Specialized Orthopedics Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K141739 |
| FEI number | 3006179046 |
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