Recall Z-1607-2024— Biomet, Inc.

Name: FDA recall Z-1607-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-13

Class II · Ongoing

Class II FDA medical device recall by Biomet, Inc., initiated 2024-03-13. It names one FDA 510(k) clearance: K050222. Product: Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a polyurethane bag, and sealed closed (inner barrier). The inner barrier is then placed into a PETG tray and sealed with Tyvek lid stock (outer barrier). The sealed double barrier system is placed into a paperboard carton with an IFU and label/indicator dots applied to the carton.. Reason: Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process..

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-03-13
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K050222 — VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGSBiomet, Inc.·cleared 2005-08-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a polyurethane bag, and sealed closed (inner barrier). The inner barrier is then placed into a PETG tray and sealed with Tyvek lid stock (outer barrier). The sealed double barrier system is placed into a paperboard carton with an IFU and label/indicator dots applied to the carton.

Reason for recall

Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.

Data sourced from openFDA. This site is unofficial and independent of the FDA.