Reported Jun 5, 2019 · Terminated

Zimmer Biomet Alvarado Knee Holder Base Plate Assembly and Foot Piece, & Alvarado II Base Plate and Foot Piece

Zimmer Surgical Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zimmer Surgical Inc · 200 W Ohio Ave · Dover, OH · 44622-9642

Is this the product you have?

Zimmer Biomet Alvarado Knee Holder Base Plate Assembly and Foot Piece, & Alvarado II Base Plate and Foot Piece

4 of 4 products

Products covered by this recall
Model / numberProduct as published
00-1320-010-00Alvarado Knee Holder Base Plate Assembly
00-1320-011-00Alvarado II Foot Piece
00-1320-210-00Alvarado II Base Plate
00-1320-211-00Product 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.
Lot codes and dates
  • All lot codes
Amount recalled
37,402

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 19, 2020 · Data as of Sep 19, 7:35 PM UTC

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