Device product
Zimmer Biomet Alvarado Knee Holder Base Plate Assembly and Foot Piece, & Alvarado II Base Plate and Foot Piece: Alvarado Foot Piece: Item Number: 00-1320-010-00 Alvarado Knee Holder Base Plate Assembly: Item Number: 00-1320-011-00 Alvarado II Foot Piece: Item Number: 00-1320-210-00 Alvarado II Base Plate: Item Number: 00-1320-211-00 Product Usage: This device is designed to hold the patient s knee in the selected position during surgery. The Alvarado Knee Holder includes a Base Plate assembly with two rows of slotted hooks. These rows extend upward from the base plate for a sufficient length to provide adequate selective adjustment. A Foot Piece is mounted on an alignment rod that is pivotally engaged into the hook portion of the slots.
Z-1494-2019
Product summary
- Event
- Event 82726
- Status
- Terminated
- Classification
- Class II
- Quantity
- 37,402
- Official record key
device-enforcement:Z-1494-2019
Official wording
Reason: Foreign Material in the Alvarado Knee Holder Base Plate Assembly and Foot Piece and Alvarado II Base Plate and Foot Piece due to potentially inadequate cleaning procedures
Code information: All lot codes
Distribution pattern: Worldwide distribution - US Nationwide and countries of AUKLAND AUSTRALIA BRAZIL CANADA CHILE Dominican Republic EL SALVADOR GUATEMALA HONG KONG INDIA JAPAN MEXICO NETHERLANDS NEW ZEALAND KOREA SINGAPORE TAIWAN VENEZUELA
Derived failure modes
-
Foreign material or chemical contamination
Foreign Material