Zimmer Biomet Recalls Vanguard Knee Bearings Due to Packaging Mix-up
Zimmer Biomet is recalling 48 Vanguard Complete Knee System tibial bearings because two lots were commingled, creating a risk that 14mm bearings are packaged in 12mm boxes or vice versa.
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 is classified as FDA Class II, and the hazard involves a risk of harm (incorrect implant size leading to extended surgery) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Zimmer Biomet, Inc. is recalling 48 units of the Vanguard Complete Knee System, specifically the E1 Vanguard PS Tibial Bearing (Model Numbers EP-183664 and EP-183642). The recall involves Lots 198810 and 210320. These products are intended for use in knee joint replacement arthroplasties.
The recall was initiated because two lots of tibial bearings were commingled. This error creates a possibility that a 14mm tibial bearing is packaged in a box labeled as a 12mm tibial bearing, or vice versa. The FDA has classified this as a Class II recall.
The affected products were distributed to accounts in California, Connecticut, Georgia, Iowa, Indiana, Louisiana, Massachusetts, Maryland, Minnesota, Mississippi, New Jersey, Ohio, Pennsylvania, Tennessee, Texas, Utah, Virginia, and Wisconsin. Foreign distribution included Taiwan, Japan, and the Netherlands. Healthcare providers and facilities should stop using these specific lots and contact Zimmer Biomet for instructions on returning the product.
The recalled product
- Product
- Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP-183642 Product Usage: The product is intended for use in knee joint replacement arthroplasties.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 48
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)
- Lots 198810 and 210320
Distribution
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