FDA recall Z-1652-2026

Product

Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;

Reason for recall

The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.

Distribution

US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA

Key facts

Status

Ongoing

Initiation date

2026-02-11

Report date

2026-04-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Norderstedt, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1652-2026