Reported Jun 18, 2025 · Ongoing
LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE PACK,…
American Contract Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Contract Systems, Inc. · 7300 W Detroit St · Chandler, AZ · 85226-2410
Is this the product you have?
- LOWER EXTREMITY
- ModelNCEX20I; LOWER EXTREMITY
- ModelNCEX20J; TOTAL KNEE PACK
- ModelNCTK31K; TOTAL KNEE PACK
- ModelNCTK31L All convenience kits contain Specialist Blend Cast Padding
- ItemQTX30-322NS
- Lot codes and dates
4 of 4 products
Products covered by this recall # Barcodes Product as published 1 00191072222398NCEX20I/00191072222398/9146304(2025-12-03), 9207685(2026-01-08) 2 00191072234582NCEX20J/00191072234582/9222096(2026-01-30), 9222096(2026-01-30) 3 00191072222480NCTK31K/00191072222480/9086225(2025-11-01), 9086225(2025-11-01) 4 00191072234872NCTK31L/00191072234872/9219596(2026-01-15), 9219596(2026-01-15) - Amount recalled
- 850 Kits
Where it was sold
- Nationwide
- CO
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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