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Medtronic Xomed, Inc. recalls Lamicel 20PK 3MM INTL Cervical dilator
Recalled January 1, 2020 · FDA recall Z-0733-2020 · Medtronic Xomed
Hazard
Routine sterilization dose does not meet the required Sterility Assurance Level. · FDA Class II
Units
29320 units
Sold at
Affected product was only distributed in Japan.
Description
Routine sterilization dose does not meet the required Sterility Assurance Level.
Product
Lamicel 20PK 3MM INTL Cervical dilator
Manufacturer(s)
Medtronic Xomed, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →