FDA-Device2018-04-04Class II
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.
Encore Medical, Lp
Hazard
Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial.
Sold states
US Nationwide Distribution
Affected count
387 units
Manufactured in
9800 Metric Blvd, Austin, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1241-2018Don't want to check this manually?
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