Nextremity Solutions Recalls Nextra Hammertoe Correction System Due to Driver Defect
Nextremity Solutions is recalling 190 units of the Nextra Hammertoe Correction System because the driver may be oversized, making it difficult to remove from the implant.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device defect that could complicate a surgical procedure, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Nextremity Solutions is recalling 190 units of the Nextra Hammertoe Correction System, reference NX-4532K. The product is a system of implants and instruments indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes. The specific lot number is 168117318B and the UDI is 00817701020011.
The recall was initiated because the proximal end of the driver in the affected product may be oversized in varying degrees. This defect potentially makes it difficult to connect with and remove the driver from the proximal Nextra implant. The agency has classified this recall as Class II.
The affected units were distributed internationally in Spain, the United Kingdom, Germany, and Switzerland. No specific instructions for consumers are provided in the source text, but the recall is managed by Nextremity Solutions.
The recalled product
- 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
- Manufacturer
- Nextremity Solutions
- Affected units
- 190
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 168117318B UDI: 00817701020011
Distribution
Distribution scope not specified by the agency.
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