Recall Z-1657-2020— Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Biomet, Inc., initiated 2020-02-26, terminated 2021-07-29. It names 2 FDA 510(k) clearances: K160071, K131135. Product: BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.. Reason: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters..
- Recalling firm
- Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-02-26
- Terminated
- 2021-07-29
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
2 on FDA's record- K160071 — StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis
- K131135 — BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS
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
BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.
Reason for recall
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Data sourced from openFDA. This site is unofficial and independent of the FDA.