Biomet, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1043-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

(1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Knee joint replacement prostheses. Item Number: 183122 EXPANDED RECALL: (2) Vanguard Knee System PS Open Box Femoral; Left; 60 mm. Item Number: 183124 (3) Vanguard Knee System PS Open Box Femoral; Left; 62.5 mm. Item Number: 183126

Product Classification:

Class II

Date Initiated: December 29, 2022

Date Posted: February 8, 2023

Recall Number: Z-1043-2023

Event ID: 91489

Reason for Recall:

Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).

Status: Ongoing

Product Quantity: 91 units

Code Information:

(1) UDI: (01)00880304270862(17)320504(10)J7186089 Lot Number: J7186089. Expanded Recall: (2)UDI: (01)00880304270879(17)320504(10)J7173870 Lot Number: J7173870. (3) UDI: (01)00880304270893(17)320504(10)J7192119; (01)00880304270893(17)320504(10)J7197508; (01)00880304270893(17)320504(10)J7209606; (01)00880304270893(17)320504(10)J7220427; Lot Numbers: J7192119, J7197508, J7209606, J7220427

Distribution Pattern:

International distribution to the countries of: Argentina, China, Costa Rica, India, Japan, Mexico, Netherlands, Ecuador, Republic of Korea, Singapore, and Thailand. Expanded Recall US states of: FL, IN, MD, OH, PA, WI

Voluntary or Mandated:

Voluntary: Firm initiated