FDA Medical Device Recalls (openFDA)
I.T.S. GmbH: Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After this, the implant has no more use and can be removed.
- Recall number
- Z-1718-2019
- Recalling firm
- I.T.S. GmbH
- Product
- Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After this, the implant has no more use and can be removed.
- Status
- Open, Classified
- Initiated
- 2019-05-09
- Posted
- not on file
- Terminated
- not on file
- Reason
- The titanium implant has the wrong article number laser marked on it.
- Root cause
- Labeling mix-ups
- Action
- I.T.S. GmbH notified international consignees initially on about 05/09/2019, via an updated "Urgent Notice MEDICAL DEVICE RECALL" letter, and US customers were notified to quarantine affected devices. On about 05/13/2019, US customers were notified via an updated "Urgent Notice MEDICAL DEVICE RECALL" letter. Customers were instructed to immediately review their inventory to identify and remove all affected products listed above in a manner that ensures the affected products will not be used, review, complete, sign and return the attached reply form and send it back within 5 business days of receipt of the notification, return any affected product as soon as possible within 30 business days and include a copy of this notification, and forward the recall notification to any appropriate parties that need to be informed about this recall. lf any of the affected products have been forwarded to another facility, customers were instructed to contact that facility to arrange return and provide them with a copy of the recall notification. A copy of this letter was instructed to be kept.
- Quantity
- 65 devices
- Distribution
- Worldwide distribution - US nationwide distribution in the states of Florida and Puerto Rico, and countries of Austria, Netherlands, Slovenia, South Africa, Switzerland.
- Lot, serial or model codes
- Model Number: 21206-10; Lot Code: 26/F42778
- 510(k) numbers
- ["K063166"]
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 3004369035
- Firm city
- Lasnitzhohe
- Firm state
- not on file
- Firm country
- Austria
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