Device product
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.
Z-0180-2016
Product summary
- Event
- Event 72229
- Status
- Terminated
- Classification
- Class II
- Quantity
- 634 units
- Official record key
device-enforcement:Z-0180-2016
Official wording
Reason: 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.
Code information: Lot # 52748L02A
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
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.