Recall Z-0733-2020 ยท LOB Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination
Medtronic Xomed, Inc.
Lamicel 20PK 3MM INTL Cervical dilator
| Date | Nov 13, 2019 |
| Status | Open, Classified |
| Reason | Routine sterilization dose does not meet the required Sterility Assurance Level. |
| Root cause | Process control |
| Action | Medtronic will send the Consignee Notification and Customer Confirmation Form (or equivalent record) to each listed consignee. Consignees will be asked to confirm receipt of FCA notification. |
| Quantity | 29320 units |
| Distribution | Affected product was only distributed in Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.