Recall Z-1718-2019
I.T.S. GmbH · initiated May 9, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Model Number: 21206-10; Lot Code: 26/F42778
Reason for recall
The titanium implant has the wrong article number laser marked on it.
FDA-determined cause: Labeling mix-ups
Action taken
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.
Details
- Recall number
- Z-1718-2019
- Initiated
- May 9, 2019
- Product code
- HRS – Plate, Fixation, Bone
- 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.
- Recalling firm
- I.T.S. GmbH, Lasnitzhohe