Recall Z-1458-2020
Nextremity Solutions · initiated February 12, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Product Usage: The Nextra Hammertoe Correction System is a system of implants and associated instruments which is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.
Codes / lots: Lot Number: 168117318B UDI: 00817701020011
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
FDA-determined cause: Under Investigation by firm
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.
Details
- Recall number
- Z-1458-2020
- Initiated
- February 12, 2020
- Posted by FDA
- February 24, 2020
- Terminated
- December 17, 2020
- Product code
- HWC – Screw, Fixation, Bone
- Quantity
- 190 units
- Distribution
- International distribution in the countries of Spain, United Kingdom, Germany, and Switzerland.
- Recalling firm
- Nextremity Solutions, Warsaw, IN