FDA Medical Device Recalls (openFDA)
Nextremity Solutions: Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrument
- Recall number
- Z-0913-2022
- Recalling firm
- Nextremity Solutions
- Product
- Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrument
- Status
- Terminated
- Initiated
- 2022-02-10
- Posted
- not on file
- Terminated
- 2024-10-10
- 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@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.
- Quantity
- 89 units
- Distribution
- Distribution US Nationwide, Japan, and the Netherlands
- Lot, serial or model codes
- Lot Number: 168125017B UDI: 00817701020059
- 510(k) numbers
- ["K110445"]
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 3009540749
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28