Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Product Usage: The Nextra
FDA device recall Z-1458-2020 · posted 2020-02-24 · Terminated
Recall details
- Recalling firm
- Nextremity Solutions
- Reason for recall
- Proximal end of the driver in the affected product may be oversized in varying degrees, potentially making it difficult to connect with and remove from the proximal Nextra implant
- Action taken
- Nextremity notified European distributors and customers of the FSCA via a Field Safety Notice dated 2/12/2020.The Field Safety Notice instructed return of all product with the specified lot number.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 190 units
- Distribution
- International distribution in the countries of Spain, United Kingdom, Germany, and Switzerland.
- Date initiated
- 2020-02-12
- Date posted
- 2020-02-24
- Date terminated
- 2020-12-17
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FLEXFUSION (TM) FIXATION IMPLANT (K110445) | Nextremity Solutions, LLC | 2011-03-17 |