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Recall Observatory FDA recall evidence

Device 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.

Z-1718-2019

May 09, 2019

Class II

Product summary

Firm
I.T.S. GmbH
Event
Event 82796
Status
Ongoing
Classification
Class II
Quantity
65 devices
Official record key
device-enforcement:Z-1718-2019

Official wording

Reason: The titanium implant has the wrong article number laser marked on it.

Code information: Model Number: 21206-10; Lot Code: 26/F42778

Distribution pattern: Worldwide distribution - US nationwide distribution in the states of Florida and Puerto Rico, and countries of Austria, Netherlands, Slovenia, South Africa, Switzerland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The titanium implant has the wrong article number laser marked on it.