Class 2 Device Recall Lamicel Cervical Dilator

• Date Initiated by Firm: November 13, 2019
• Create Date: December 23, 2019
• Recall Status: Open, Classified
• Recall Number: Z-0735-2020
• Recall Event ID: 84332
• PMA Number: P820075
• Product Classification: dilator, cervical, synthetic, osmotic, pregnancy termination - Product Code LOB
• Product: Lamicel 10PK 10MM INTL
• Code Information: UDI: 20613994728917; SPONGE 2205-501EX LAMICEL 10PK 10MM INTL; 2205-501EX; Lots 9767987, 9806170
• FEI Number: 1045254
• Recalling Firm/ Manufacturer: Medtronic Xomed, Inc.; 6743 Southpoint Dr N; Jacksonville FL 32216-6218
• For Additional Information Contact: Mike Tomberlin; 904-281-2769
• Manufacturer Reason for Recall: Routine sterilization dose does not meet the required Sterility Assurance Level.
• FDA Determined 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 in Commerce: 10 packs; 100 units
• Distribution: Affected product was only distributed in Japan.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = LOB