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Open, Classified

Lamicel 10PK 10MM INTL

FDA Recall Z-0735-2020 · Posted None

Recalling FirmMedtronic Xomed, Inc.
Recall StatusOpen, Classified
Product CodeLOB
Date Initiated2019-11-13
Product Quantity10 packs; 100 units

Reason for Recall

Routine sterilization dose does not meet the required Sterility Assurance Level.

Firm 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.

Root Cause

Process control

Distribution Pattern

Affected product was only distributed in Japan.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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