Recall Z-1652-2020— 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: K161166, K080979. Product: BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM, Silicone, Sterile, Item 431199.. 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- K161166 — StageOne Select Cement Spacer Molds for Temporary Hip Replacement
- K080979 — STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT
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 Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM, Silicone, Sterile, Item 431199.
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.