Recall Z-1494-2019— Zimmer Surgical Inc

Class II FDA medical device recall by Zimmer Surgical Inc, initiated 2019-04-16, terminated 2020-05-19. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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.

Recalling firm

Zimmer Surgical Inc

Classification

Class II

Status

Terminated

Initiated

2019-04-16

Terminated

2020-05-19

Firm location

Dover, OH, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.