TOTAL KNEE -Procedure Kit Catalog Number: QPTK95A
Reported: July 17, 2024 Initiated: May 15, 2024 #Z-2293-2024
Product Description
TOTAL KNEE -Procedure Kit Catalog Number: QPTK95A
Reason for Recall
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
Details
- Recalling Firm
- American Contract Systems Inc
- Units Affected
- 50 units
- Distribution
- US Nationwide distribution.
- Location
- Tiffin, OH
Frequently Asked Questions
What product was recalled? ▼
TOTAL KNEE -Procedure Kit Catalog Number: QPTK95A. Recalled by American Contract Systems Inc. Units affected: 50 units.
Why was this product recalled? ▼
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 17, 2024. Severity: Moderate. Recall number: Z-2293-2024.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11