FDA-Device2015-11-04Class II
Reverse Shoulder Prosthesis Stem Impaction Fixture REF 804-03-053 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to assemble the shoulder systems for implant. The Turon Fixture is used to connect the Humeral Head to the Humeral Neck, then subsequently to assemble the Humeral Stem to the Head/Neck construct. The RSP Fixture is used to assemble the UHMWPE Socket Inserts to both the RSP Socket Shells and Monoblock Stems.
Encore Medical, Lp
Hazard
During the assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating.
Sold states
Nationwide Distribution
Affected count
634 units
Manufactured in
9800 Metric Blvd, N/A, Austin, TX, United States
Products
Reverse Shoulder Prosthesis Stem Impaction Fixture REF 804-03-053 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to assemble the shoulder systems for implant. The Turon Fixture is used to connect the Humeral Head to the Humeral Neck, then subsequently to assemble the Humeral Stem to the Head/Neck construct. The RSP Fixture is used to assemble the UHMWPE Socket Inserts to both the RSP Socket Shells and Monoblock Stems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0180-2016Don't want to check this manually?
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