FDA recall Z-2399-2026

Product

Hintermann Series Talar Implant, Left, Size 2 REF 302112

Reason for recall

Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.

Distribution

Worldwide - US Nationwide distribution in the states of CA, AR, AZ, ID and the countries of PER, KOR.

Key facts

Status

Ongoing

Initiation date

2026-03-24

Report date

2026-06-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mcminnville, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2399-2026