An FDA-recorded root-cause determination. The FDA lists 28 recalls with this root cause since 2025. Most recent report: Jun 17, 2026.
Sterile anchors my lack sterility assurance.
Certain lots of product have the potential for a sterile barrier breach.
Certain lots of product have the potential for a sterile barrier breach.
Certain lots of product have the potential for a sterile barrier breach.
Certain lots of product have the potential for a sterile barrier breach.
Certain lots of product have the potential for a sterile barrier breach.
Certain lots of product have the potential for a sterile barrier breach.
Certain lots of product have the potential for a sterile barrier breach.
Certain lots of product have the potential for a sterile barrier breach.
Certain lots of product have the potential for a sterile barrier breach.
Due to labeling error. Incomplete ingredients listed. Labeling did not include castor oil or calamine.
Removal of affected lot of screws due to labeling error.
Source: U.S. FDA openFDA device enforcement + RES recall records. Informational only — verify against the FDA before acting.