RecallRadar

FDA Device recall Z-0911-2022

Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC Orthopedic surgical instrument

On 2022-04-20 the FDA classified a Class II recall of Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC Orthopedic surgical instrument by Nextremity Solutions, citing 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.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0911-2022
ClassificationClass II
Statusterminated
Initiated2022-02-10
Published2022-04-20
Last updated2026-09-13 11:56 UTC
CompanyNextremity Solutions
DistributionUS

Product

Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC Orthopedic surgical instrument

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

Identifiers

code_infoLot Number: 168117318C, 168125017D UDI: 00817701020004

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0911-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.