FDA recall Z-1657-2025

Product

MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;

Reason for recall

Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus the required 5.0mm.

Distribution

US Nationwide distribution in the state of AR.

Key facts

Status

Ongoing

Initiation date

2025-04-03

Report date

2025-04-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Norriton, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1657-2025