Recall Z-1916-2025 ยท OJH Orthopedic Tray
American Contract Systems, Inc.
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
| Date | Jun 6, 2025 (initiated Apr 21, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Finished device change control |
| Action | On 4/21/2025, correction notices were emailed to the customer who was asked to do the following: 1) Discontinue use of the Cast Padding component. All other components within the kit can be used. 2) Add warning labels to affected kits in Table 2 to ensure the component is discarded. A labeling template is enclosed for printing labels which can be affixed on all affected kits in inventory. This label should be applied to each affected Procedure tray and product case in a prominently visible location to end-users. The location chosen should not cover any other critical product information found |
| Quantity | 850 Kits |
| Distribution | US Nationwide distribution in the state of CO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.