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U.S. Department of Health and Human Services

Class 2 Device Recall Lamicel Cervical Dilator

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  Class 2 Device Recall Lamicel Cervical Dilator see related information
Date Initiated by Firm November 13, 2019
Create Date December 23, 2019
Recall Status1 Open3, 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
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 2		 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 and Original Applicant = Medtronic Xomed, Inc.
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