The Recall Desk
HighFDA (Devices)·Z-1916-2025·Announced 2025-06-18

[pending] LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K

Pending LLM rewrite. Source: FDA_DEVICE Z-1916-2025.

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

Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals exceeded residual limits, which may lead to a possible loss or lack of functionality that may lead to a delay or prolonged treatment/procedure/therapy.

The recalled product

Product
LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE PACK, Model: NCTK31L All convenience kits contain Specialist Blend Cast Padding, Item: QTX30-322NS
Manufacturer
American Contract Systems, Inc.
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 (8)

  • Model/UDI-DI/Lot(Expiration): NCEX20I/00191072222398/9146304(2025-12-03)
  • 9207685(2026-01-08)
  • NCEX20J/00191072234582/9222096(2026-01-30)
  • 9222096(2026-01-30)
  • NCTK31K/00191072222480/9086225(2025-11-01)
  • 9086225(2025-11-01)
  • NCTK31L/00191072234872/9219596(2026-01-15)
  • 9219596(2026-01-15)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category