Zimmer Biomet Alvarado Knee Holder Recalled for Foreign Material
Zimmer Surgical Inc is recalling Alvarado and Alvarado II knee holder components due to potentially inadequate cleaning procedures that may leave foreign material on the devices.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm due to foreign material, but the source text does not report any specific injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Zimmer Surgical Inc is voluntarily recalling the Alvarado Knee Holder Base Plate Assembly and Foot Piece, as well as the Alvarado II Base Plate and Foot Piece. The recall is being conducted because potentially inadequate cleaning procedures may have resulted in foreign material remaining on the devices.
The affected products include the 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), and Alvarado II Base Plate (Item Number 00-1320-211-00). A total of 37,402 units are involved in this recall, which covers all lot codes. These devices are designed to hold a patient's knee in a selected position during surgery.
The products were distributed worldwide, including in the United States and various international locations such as Australia, Brazil, Canada, and Japan. Healthcare facilities and distributors should stop using the affected devices and contact Zimmer Surgical Inc for further instructions on the recall process.
The recalled product
- 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…
- Manufacturer
- Zimmer Surgical Inc
- Affected units
- 37,402
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lot codes
Distribution
Distributed nationwide across the United States.
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