WhichRecall
Class IIReported 2026-04-01

Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2. Spike short; Article Number: 70314.

Recalled by I.T.S. GmbH

Reason for Recall

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

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Recall Number
Z-1600-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2026-01-23
Reported
2026-04-01
Distribution
US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.
Code Info
1. Article Number (Lot Number): 70312 (26/F65133). 2. Article Number (Lot Number): 70314 (86/619736).
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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