Z-0735-2020Class II

Lamicel 10PK 10MM INTL

Name: Z-0735-2020 Lamicel 10PK 10MM INTL
Creator: Medtronic Xomed, Inc.
Published: 2019-11-13
License: https://open.fda.gov/license/

Medtronic Xomed, Inc. / initiated 2019-11-13 / Open, Classified / root cause: manufacturing process

FDA source

Medtronic Xomed, Inc. began a recall of Lamicel 10PK 10MM INTL on 2019-11-13. FDA classified it as Class II and gives the reason as "Routine sterilization dose does not meet the required Sterility Assurance Level". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0735-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-11-13
Posted: 2019-12-23
Recalling firm: Medtronic Xomed, Inc.
Product: Lamicel 10PK 10MM INTL
Product code: LOB Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination
Reason for recall: Routine sterilization dose does not meet the required Sterility Assurance Level.
Root cause tag: manufacturing process
FDA 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 in commerce: 10 packs; 100 units
Distribution: Affected product was only distributed in Japan.
Product codes and lots: UDI: 20613994728917; SPONGE 2205-501EX LAMICEL 10PK 10MM INTL; 2205-501EX; Lots 9767987, 9806170

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0735-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0733-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-01-01	2019-12-23
Z-0734-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-01-01	2019-12-23
Z-0735-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-01-01	2019-12-23

Product code LOB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)