FDA Medical Device Recalls (openFDA)
Medtronic Xomed, Inc.: Lamicel 10PK 10MM INTL
- Recall number
- Z-0735-2020
- Recalling firm
- Medtronic Xomed, Inc.
- Product
- Lamicel 10PK 10MM INTL
- Status
- Open, Classified
- Initiated
- 2019-11-13
- Posted
- not on file
- Terminated
- not on file
- Reason
- Routine sterilization dose does not meet the required Sterility Assurance Level.
- 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
- 10 packs; 100 units
- Distribution
- Affected product was only distributed in Japan.
- Lot, serial or model codes
- UDI: 20613994728917; SPONGE 2205-501EX LAMICEL 10PK 10MM INTL; 2205-501EX; Lots 9767987, 9806170
- 510(k) numbers
- not on file
- PMA numbers
- ["P820075"]
- Product code
- LOB
- Firm FEI
- 1045254
- Firm city
- Jacksonville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28