Drug recall
NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/Item Number/Product…
FDA recall event 89001 · Class II · NuVasive Specialized Orthopedics, Inc.
Key facts
| Event ID | 89001 |
|---|---|
| Recall numbers | Z-0319-2022 |
| Recalling firm | NuVasive Specialized Orthopedics, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh 50 lbs. or more while… |
| Initiation date | Oct 29, 2021 |
| Report date | Dec 8, 2021 |
| City | Aliso Viejo |
| State | CA |
| Country | United States |
| FEI number | 3006179046 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: