The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0111-2017·Announced 2016-10-26

Zimmer Biomet Recalls Vanguard Distal Femoral Augments Due to Labeling Error

Zimmer Biomet is recalling five Vanguard Distal Femoral Augments because the product inside the carton does not match the label. The mismatched size is easily identified during surgery.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall involving a labeling error where the hazard is easily identified during surgery, resulting in a minor delay rather than significant injury.

Plain-English summary

Zimmer Biomet, Inc. is recalling five units of the Vanguard Distal Femoral Augment 75 X 5 RL/LM. The recall was initiated because the contents of the package do not match the product labeling. Specifically, the carton is labeled for the RL/LM model, but it contains the LL/RM model.

The affected product is a single-use implant intended for knee joint procedures. The distribution pattern includes the United States (New Jersey, Michigan, Florida) and international locations in Sweden and Canada. The specific item number is 184108, lot number 183410, with an expiration date of 8/27/2025.

The FDA classifies this as a Class II recall. The stated risk is a delay of less than 30 minutes and the use of a different size augment to complete the procedure. The source text notes that the augment will not assemble with the femoral component due to its shape, meaning it would be easily identified during surgery. No illnesses or injuries have been reported in the source text.

The recalled product

Product
Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage:  Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.  Correction of varus, valgus, or posttraumatic deformity. …
Manufacturer
Zimmer Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
5

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)

  • Item Number 184108 Lot Number 183410 Exp. 8/27/2025

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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