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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 Dilatorsee related information
Date Initiated by FirmNovember 13, 2019
Create DateDecember 23, 2019
Recall Status1 Open3, Classified
Recall NumberZ-0733-2020
Recall Event ID 84332
PMA NumberP820075 
Product Classification dilator, cervical, synthetic, osmotic, pregnancy termination - Product Code LOB
ProductLamicel 20PK 3MM INTL Cervical dilator
Code Information UDI: 20885074749024; SPONGE 2202-501EX LAMICEL 20PK 3MM INTL; 2202-501EX; Lots 9646605, 9651239, 9651240, 9651245, 9667694, 9667697, 9667756, 9669946, 9686127, 9686128, 9688076, 9693346, 9693347, 9693339, 9775264, 9799705, 9799708, 9811174, 9812616, 9819177, 9819513, 9819516, 9851438
Recalling Firm/
Manufacturer		 Medtronic Xomed, Inc.
6743 Southpoint Dr N
Jacksonville FL 32216-6218
For Additional Information ContactMike 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
ActionMedtronic 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 Commerce29320 units
DistributionAffected product was only distributed in Japan.
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = LOB
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