Encore Medical, Lp recalls Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 804-07-420 Product Usage: The AltiVate Anat…

Recall date

January 29, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1257-2018

FDA classification

Class II

Brand / firm

Encore Medical, Lp

Sold / distributed

US Nationwide Distribution

Why it was recalled

It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the implants

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 804-07-420 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.