Recall Z-1718-2019— I.T.S. GmbH

Name: FDA recall Z-1718-2019
Creator: U.S. Food and Drug Administration
Published: 2019-05-09

Class II · Ongoing

Class II FDA medical device recall by I.T.S. GmbH, initiated 2019-05-09. It names one FDA 510(k) clearance: K063166. 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.. Reason: The titanium implant has the wrong article number laser marked on it..

Recalling firm: I.T.S. GmbH
Classification: Class II
Status: Ongoing
Initiated: 2019-05-09
Firm location: Lasnitzhohe, Austria

510(k) clearances named in this recall

1 on FDA's record

K063166 — I.T.S. PELVIC RECONSTRUCTION SYSTEMI.T.S. Implantat-Technologie-Systeme GmbH·cleared 2006-12-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.