FDA Enforcement
Class II
Terminated
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.
Recall: Z-0180-2016
·
Reported November 4, 2015
Enforcement
- Recall Number
- Z-0180-2016
- Event ID
- 72229
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Encore Medical, Lp
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 4, 2015
- Initiation Date
- September 14, 2015
- Classification Date
- October 28, 2015
- Termination Date
- November 4, 2016
- Address
- 9800 Metric Blvd, N/A, Austin, TX, 78758-5445, United States
Description
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.
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 Info
Lot # 52748L02A
Distribution
Nationwide Distribution
Quantity
634 units