The Recall Desk
HighFDA (Devices)·Z-1605-2026·Announced 2026-04-01

[pending] FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below description

Pending LLM rewrite. Source: FDA_DEVICE Z-1605-2026.

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
FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1. FLS - Foot Locking Plates System, Cancellous Stabilization Screw; Article Numbers: 37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 373
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): 37303-10 (18/151720
  • 18/268729
  • 679/032432
  • 679/072268
  • 679/102237
  • 679/102307)
  • 37303-12 (18/570637
  • 679/032434
  • 679/072269
  • 679/102346
  • 679/112227)
  • 37303-14 (18/751091
  • 26/F66913
  • 679/012510
  • 679/062288
  • 679/102359
  • 679/112410)
  • 37303-16 (679/072263
  • 679/102245
  • 18/151841

Distribution

Distributed nationwide across the United States.

Related recalls

Same category