Zimmer Biomet Alvarado Knee Holder Base Plate Assembly and Foot Piece — Class II medical device recall Z-1494-2019
Terminated recall by Zimmer Surgical Inc, reported 2019-06-05, distributed nationwide. Foreign Material in the Alvarado Knee Holder Base Plate Assembly and Foot Piece and Alvarado II Base Plate and
| Recall number | Z-1494-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Surgical Inc, Dover, OH, United States |
| Recall initiated | 2019-04-16 |
| Classified | 2019-05-28 |
| Reported by FDA | 2019-06-05 |
| Terminated | 2020-05-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, CL, DO, GT, HK, IN, JP, KR, MX, NL, NZ, SG, SV, TW, VE |
| Quantity | 37,402 |
| Reason classes | foreign material |
| Model numbers | 00-1320-010-00, 00-1320-011-00, 00-1320-210-00, 00-1320-211-00 |
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 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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.