BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.
FDA device recall Z-1643-2020 · posted 2020-04-03 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- Action taken
- On 2/26/2020, Zimmer Biomet sent an "Urgent Medical Device Recall" letter via FEDEX to direct sales distributors, hospitals, and surgeons. In addition, an email was sent to all distributors alerting them of the recall. Customers were instructed to quarantine the product and a Zimmer Biomet representative would remove the affected product from the facility. They asked customers to complete and return the "Certificate of Acknowledgement" form indicating whether they had any of the affected lots.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KWY
- Quantity affected
- 230,001
- Distribution
- Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, India
- Date initiated
- 2020-02-26
- Date posted
- 2020-04-03
- Date terminated
- 2021-07-29
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| StageOne Select Cement Spacer Molds for Temporary Hip Replacement (K161166) | Biomet, Inc. | 2016-09-08 |
| STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT (K080979) | Biomet Manufacturing Corp | 2008-10-31 |