Lamicel 10PK 10MM INTL
- Company
- Medtronic Xomed, Inc.
- Recall Initiated
- November 13, 2019
- Recall Number
- Z-0735-2020
- Quantity
- 10 packs; 100 units
- Firm Location
- Jacksonville, FL
Reason for Recall
Routine sterilization dose does not meet the required Sterility Assurance Level.
Distribution
Affected product was only distributed in Japan.
Lot / Code Info
UDI: 20613994728917; SPONGE 2205-501EX LAMICEL 10PK 10MM INTL; 2205-501EX; Lots 9767987, 9806170
Root Cause
Process control
Action Taken
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.
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