Recall Z-0910-2022 ยท HWC Screw, Fixation, Bone
Nextremity Solutions
Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgical instrument
| Date | Feb 10, 2022 |
| Status | Terminated |
| Reason | 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 |
| Root cause | Nonconforming Material/Component |
| 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 CorporateQuality.PostMarket@zim |
| Quantity | 4 units |
| Distribution | Distribution US Nationwide, Japan, and the Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110445 | FLEXFUSION (TM) FIXATION IMPLANT Nextremity Solutions, LLC, Mar 17, 2011 |