medical Class II Updated 2018-04-04

Encore Medical, Lp recalls Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL,

Recalled Product

Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All Serial Numbers
View official government recall

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