The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1042-2023·Announced 2023-02-08

Vanguard Knee System Prosthesis Components Incorrectly Labeled for Size and Side

Biomet is recalling 157 units of Vanguard Knee System prosthesis components incorrectly labeled as different sizes or surgical sides. Surgeons relying on labels could implant the wrong size or side, requiring corrective 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 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: This is a Class II recall with no reported illnesses or injuries in the source text. However, the labeling error affects surgical prosthesis components, which are high-risk products. Implanting the wrong size or side would cause patient harm requiring corrective surgery. This fits the criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Biomet, Inc. is recalling 157 units of Vanguard Knee System PS Open Box Femoral prosthesis components in five size variants (60mm, 62.5mm, 65mm, 67.5mm, and 70mm). These components have been distributed internationally to Argentina, China, Costa Rica, India, Japan, Mexico, Netherlands, Ecuador, Republic of Korea, Singapore, and Thailand, as well as to six US states: Florida, Indiana, Maryland, Ohio, Pennsylvania, and Wisconsin.

The recalled components are labeled incorrectly—some are marked as a different size than they actually are, and some are labeled for the wrong surgical side (right vs. left). Because surgical teams rely on product labels to select the correct implant, an incorrectly labeled component could result in implanting the wrong size or side, which would require corrective surgery.

Healthcare facilities that may have received these products should check their inventory against the provided lot numbers and UDI codes, segregate any affected units, and contact their supplier or Biomet directly. Patients who are concerned about previously implanted components should consult with their surgical team.

The recalled product

Product
(1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses. Item Number: 183104 (2) Vanguard Knee System PS Open Box Femoral; Right; 62.5 mm Item Number: 183106 (3) Vanguard Knee System PS Open Box Femoral; Right; 65 mm Item…
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Prosthesis
Hazard
Affected units
157

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 (2)

  • J7215873 (01)00880304270770(17)320428(10)J7215873
  • J7220365 (01)00880304270770(17)320504(10)J7220365

Distribution

Distributed in 6 states:

Part of a larger recall action

This product is one of 2 recalled by Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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