Nextremity Solutions recalls Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital re…

Recall date

January 13, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0740-2022

FDA classification

Class II

Brand / firm

Nextremity Solutions

Sold / distributed

US Nationwide distribution in the states of AZ, IL, GA, LA, MD, NY, PA, TX, WA.

Why it was recalled

During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal phalanx implants, resulting in surgical delay, in-situ removal of the implant, use of alternative surgical approach, disassembly of the implants post-operatively, and revision

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toe SKU: CH-STD-KT