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Encore Medical, Lp recalls AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Ort
Recalled April 4, 2018 · FDA recall Z-1241-2018 · Encore Medical
Hazard
Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial. · FDA Class II
Units
387 units
Sold at
US Nationwide Distribution
Description
Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial.
Product
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.
Manufacturer(s)
Encore Medical, Lp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →