FDA Medical Device Recalls (openFDA)
Medtronic Xomed, Inc.: Lamicel 20PK 3MM INTL Cervical dilator
- Recall number
- Z-0733-2020
- Recalling firm
- Medtronic Xomed, Inc.
- Product
- Lamicel 20PK 3MM INTL Cervical dilator
- 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
- 29320 units
- Distribution
- Affected product was only distributed in Japan.
- Lot, serial or model codes
- 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
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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