Recall Z-2145-2020— Biomet, Inc.

Name: FDA recall Z-2145-2020
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: K051411. Product: Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM 2) 11-165218 RingLoc Bi-Polar Hip System, Acetabular Cup, 28 MM X 47 MM 3) XL-105916 588500 RingLoc Hip System, Acetabular Liner, 36 MM, Size 26 Product Usage: Hemi hip arthroplasty.. 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

K051411 — ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADSBiomet, Inc.·cleared 2005-06-29

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

Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM 2) 11-165218 RingLoc Bi-Polar Hip System, Acetabular Cup, 28 MM X 47 MM 3) XL-105916 588500 RingLoc Hip System, Acetabular Liner, 36 MM, Size 26 Product Usage: Hemi hip arthroplasty.

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.