Biomet StageOne Select Hip Stem Cement Spacer Mold Recall: Potential Cleaning Process

Where it was distributed

Distributed in 48 states and D.C., and outside the U.S.

• Listed by the agency
• Not listed

FDA distribution: “Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

1. 1Feb 26, 2020Firm started the recall
2. 2Apr 3, 2020FDA classified it Class II
3. 3Apr 15, 2020Published in FDA’s Enforcement Report
4. 4Jul 29, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.