Zimmer Surgical Inc: 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.

Recall number

Z-1494-2019

Recalling firm

Zimmer Surgical Inc

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.

Status

Terminated

Initiated

2019-04-16

Posted

not on file

Terminated

2020-05-19

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

Root cause

Device Design

Action

Zimmer Biomet issued letter on 4/10/19 via email to distributors; and Hospital risk managers, as well as distributors with product notified via courier. Distributors letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their territory, as well as identifying hospitals who have unconsumed inventory on hand. Distributors will return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the form provided in the letter. Hospital risk managers provided with a letter identifying the issue and their responsibilities. These responsibilities include: - Locating and returning the product in their territory. - Returning Attachment 1 (Certificate of Acknowledgement) to Zimmer Biomet. Questions or concerns after reviewing this notice, please call customer service at 800-830-0970 between 8:00 am and 5:00pm EST, Monday through Friday. Updates to the FAQ (clarification) sent via email on April 19 to distributors.

Quantity

37,402

Distribution

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

Lot, serial or model codes

All lot codes

510(k) numbers

not on file

PMA numbers

not on file

Product code

JEB

Firm FEI

1526350

Firm city

Dover

Firm state

OH

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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