Recall Z-1665-2020— 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: K161273, K050210. Product: BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.. 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- K161273 — StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis
- K050210 — DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES
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 Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.
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.