FDA recall Z-1940-2025

Product

Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.

Reason for recall

Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.

Distribution

Worldwide - US Nationwide distribution in the states of California and Missouri. The countries of Belgium, Japan, Netherlands.

Key facts

Status

Ongoing

Initiation date

2025-05-22

Report date

2025-06-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Selzach, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1940-2025