FDA recall Z-1111-2019

Product

Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures REF # 370824 Product Usage: Ophthalmic techniques-utilized in Cataract and Glaucoma procedures

Reason for recall

Mislabeled. The package labeling indicates a size 2.4mm, 45 degree Double Bevel knife however, the marking on device shows a 2.75mm size device

Distribution

Worldwide Distribution - US Nationwide Foreign:UNITED KINGDOM JAPAN NETHERLANDS

Key facts

Status

Terminated

Initiation date

2019-03-12

Report date

2019-04-17

Termination date

2020-08-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1111-2019