Recall Z-0629-2021— Biomet, Inc.

Name: FDA recall Z-0629-2021
Creator: U.S. Food and Drug Administration
Published: 2020-11-25

Class II · Terminated

Class II FDA medical device recall by Biomet, Inc., initiated 2020-11-25, terminated 2024-05-08. It names one FDA 510(k) clearance: K972322. Product: Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - Product Usage: Fixation of Cranial bone. Reason: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device..

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-11-25
Terminated: 2024-05-08
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K972322 — LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATESWalter Lorenz Surgical, Inc.·cleared 1997-08-18

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

Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - Product Usage: Fixation of Cranial bone

Reason for recall

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

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