Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC Orthopedic surgical instrument
FDA Recall Z-0911-2022 · Posted None
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Recalling FirmNextremity Solutions
Recall StatusTerminated
Product CodeHWC
Date Initiated2022-02-10
Date Terminated2024-10-10
Product Quantity459 units
Reason for Recall
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
Firm Action
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
[email protected], 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 [email protected].
Root Cause
Nonconforming Material/Component
Distribution Pattern
Distribution US Nationwide, Japan, and the Netherlands
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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