Nextremity Solutions Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgical instrument Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgical instrument
Brand
Nextremity Solutions
Lot Codes / Batch Numbers
Lot Number: 168117318B, 168125017C UDI: 00817701020011
Products Sold
Lot Number: 168117318B, 168125017C UDI: 00817701020011
Nextremity Solutions is recalling Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgical due to Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, cau. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
Recommended Action
Per FDA guidance
Nextremity Solutions issued Urgent Medical Device Recall letter on 2/10/22 via mail and email to Distributors and Risk Mangers. Nextremity Solutions products with the referenced part and lot number should not be used and should be quarantined and returned to Zimmer Biomet for return to Nextremity Solutions. If you have affected product at your facility, locate and quarantine affected product in your inventory. Zimmer Biomet Sales representative will remove the affected product from your facility. Complete Medical Device Recall Return Response and send to CorporateQuality.PostMarket@zimmerbiomet.com, even if you do not have affected products at your facility. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Or email to CorporateQuality.PostMarket@zimmerbiomet.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026