Z-1718-2019Class II

Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable -

Name: Z-1718-2019 Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable -
Creator: I.T.S. GmbH
Published: 2019-05-09
License: https://open.fda.gov/license/

I.T.S. GmbH / initiated 2019-05-09 / Open, Classified / root cause: labeling and UDI

FDA source

I.T.S. GmbH began a recall of Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has... on 2019-05-09. FDA classified it as Class II and gives the reason as "The titanium implant has the wrong article number laser marked on it". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1718-2019
Classification: Class II
Status: Open, Classified
Initiated: 2019-05-09
Posted: 2019-06-04
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.
Product code: HRS Plate, Fixation, Bone
Reason for recall: The titanium implant has the wrong article number laser marked on it.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: Model Number: 21206-10; Lot Code: 26/F42778

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1718-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1718-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-06-12	2019-06-04

Product code HRS

K063166Class III.t.s. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH / cleared 2006-12-22

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)