Device recall
Z-0319-2022: NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System…
FDA device recall · Class II · NuVasive Specialized Orthopedics, Inc.
Key facts
| Recall number (Z-number) | Z-0319-2022 |
|---|---|
| Recall event | 89001 |
| Product | NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/Item Number/Product Description: CPA1-000 PA0382-001 End Cap CPA2-000 PA1051-000 PACKAGED END CAP, 8.5/ 10.7MM, +0MM CPA2-005 PA1051-005 PACKAGED END CAP, 8.5/ 10.7MM, +5MM CPA2-010 PA1051-010 PACKAGED END CAP… |
| Product code | HSB |
| Recalling firm | NuVasive Specialized Orthopedics, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K101997 |
| 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