The Recall Desk
HighFDA (Devices)·Z-1608-2026·Announced 2026-04-01

[pending] Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions a

Pending LLM rewrite. Source: FDA_DEVICE Z-1608-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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

The recalled product

Product
Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions and corresponding article numbers. 1. Anterior Column Plate; Article Numbers: 21218-16, 21219-16. 2. Anterior Column Plate; Article Numbers: 21218-14, 21219-14. 3. Biplanar 2-C
Manufacturer
I.T.S. GmbH
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 1. Article Number (Lot Numbers): 21218-16 (679/112166
  • 679/122229
  • 679/122230
  • 679/122304)
  • 21219-16 (679/012441
  • 679/062456
  • 679/0624561
  • 679/112167
  • 679/122228). 2. Article Number (Lot Numbers): 21218-14(679/032417
  • 679/102231
  • 679/112158
  • 679/112164
  • 679/122231)
  • 21219-14 (679/012505
  • 679/112159
  • 679/112165
  • 679/122227
  • 679/122305). 3. Article Number (Lot Numbers): 21216-10 (679/032501
  • 679/062453
  • 679/072276

Distribution

Distributed nationwide across the United States.

Related recalls

Same category