Nextra Hammertoe Correction System surgical instruments recalled for defective connector
Nextremity Solutions recalls 459 units of the Nextra Hammertoe Correction System due to an oversized proximal driver end that prevents proper connection and removal during surgery.
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: Class II medical device with a manufacturing defect affecting critical surgical function. No illnesses or injuries reported to date, but the defect poses risk of harm during orthopedic surgery if the implant cannot be properly seated or removed.
Plain-English summary
The Nextra Hammertoe Correction System is a surgical instrument used in orthopedic hammertoe correction procedures. Nextremity Solutions is recalling 459 units distributed nationwide in the US, Japan, and the Netherlands (Lot Numbers 168117318C and 168125017D, UDI 00817701020004).
The proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant during surgery. This defect causes delays in surgical procedures and creates risk of potential surgical complications.
Patients who have had or are scheduled for procedures using affected instruments should contact their healthcare provider. Healthcare facilities and surgeons should verify lot numbers and contact Nextremity Solutions. No illnesses or injuries have been reported as of the recall issuance.
The recalled product
- Product
- Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC Orthopedic surgical instrument
- Manufacturer
- Nextremity Solutions
- Hazard
- surgical-defect
- connector-failure
- assembly-malfunction
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 (2)
- Lot Number: 168117318C
- 168125017D UDI: 00817701020004
Distribution
Distributed nationwide across the United States.
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