FDA recall Z-1258-2024

Product

Embrace Drill Tower, Standard/Lateral (25mm)

Reason for recall

The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.

Distribution

US Nationwide distribution in the states of AL and LA.

Key facts

Status

Ongoing

Initiation date

2024-01-29

Report date

2024-03-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Norderstedt, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1258-2024