Z-1494-2019Class II

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

Name: Z-1494-2019 Zimmer Biomet Alvarado Knee Holder Base Plate Assembly and Foot Piece, & Alvarado II Base Plate and Foot...
Creator: Zimmer Surgical Inc
Published: 2019-04-16
License: https://open.fda.gov/license/

Zimmer Surgical SA / initiated 2019-04-16 / Terminated / root cause: design

FDA source

Zimmer Surgical Inc began a recall of Zimmer Biomet Alvarado Knee Holder Base Plate Assembly and Foot Piece, & Alvarado II Base Plate and Foot Piece: Alvarado Foot Piece: Item Number... on 2019-04-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1494-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-16
Posted: 2019-05-28
Terminated: 2020-05-19
Recalling firm: Zimmer Surgical SA
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.
Product code: JEB Table, Surgical With Orthopedic Accessories, Manual
Reason for recall: 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 tag: design
FDA 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 in commerce: 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
Product codes and lots: All lot codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1494-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1494-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-05	2019-05-28

Product code JEB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)