Encore Medical, Lp recalls AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Ort…

Recall date

January 30, 2018

Source

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

Recall number

Z-1241-2018

FDA classification

Class II

Brand / firm

Encore Medical, Lp

Sold / distributed

US Nationwide Distribution

Why it was recalled

Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial.

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 Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical instrument. Product Usage: The humeral socket shell trial is used to replicate/trial the shell geometry of the AltiVate Reverse Standard Shell Humeral Stem implants. It assembles to the humeral broaches by a screw in order to replicate/trial the entire humeral stem implant geometry prior to implantation.