FDA Devices recall · Reported June 5, 2019
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 assem
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
Zimmer Surgical Inc recalled Zimmer Biomet Alvarado Knee Holder Base Plate Assembly and Foot Piece, & Alvarado II Base… - a moderate-severity action.
Zimmer Biomet Alvarado Knee Holder Base Plate Assembly and Foot Piece, & Alvarado II Base… was recalled by Zimmer Surgical Inc in June 5, 2019. Reason: Foreign Material in the Alvarado Knee Holder Base Plate Assembly and Foot Piece and Alvarado II Base Plate an…. Check the official notice for the remedy. Verify recall #Z-1494-2019 with the FDA Devices before acting.
The recall
Zimmer Surgical Inc issued this moderate-severity FDA Devices recall-Foreign Material in the Alvarado Knee Holder Base Plate Assembly and Foot Piece and Alvarado II Base Plate an….
- Moderate
- severity level
- 37K units
- affected scope
- Class II
- classification
- June 5, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1494-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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 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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1494-2019 |
| Date reported | June 5, 2019 |
| Date initiated | April 16, 2019 |
| Recalling firm | Zimmer Surgical Inc |
| Firm location | Dover, OH |
| Affected scope | 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 ZEALAN… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1494-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026