Recall Z-2151-2020— Biomet, Inc.

Name: FDA recall Z-2151-2020
Creator: U.S. Food and Drug Administration
Published: 2020-04-17

Class II · Terminated

Class II FDA medical device recall by Biomet, Inc., initiated 2020-04-17, terminated 2021-06-25. It names one FDA 510(k) clearance: K060525. Product: Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM 189720 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 83 MM 189320 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 83 MM 189700 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 79 MM 189704 Vanguard Knee System, CR Mono Lock Tibial Bearing, 14 MM X 79 MM Product Usage: Knee prosthesis. Reason: Potential presence of elevated endotoxin levels that exceed the specification limit.

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-04-17
Terminated: 2021-06-25
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K060525 — VANGUARD REMOVABLE MOLDED POLY TIBIABiomet Manufacturing Corp·cleared 2006-05-25

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

Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM 189720 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 83 MM 189320 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 83 MM 189700 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 79 MM 189704 Vanguard Knee System, CR Mono Lock Tibial Bearing, 14 MM X 79 MM Product Usage: Knee prosthesis

Reason for recall

Potential presence of elevated endotoxin levels that exceed the specification limit

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