Recall Z-2886-2026 ยท LXH Orthopedic Manual Surgical Instrument
United Orthopedic Corp.
Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number: 9323-5335, 9323-5337, 9323-5339 and 9323-5336, 9323-5338, 9323-5340 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No
| Date | Aug 5, 2026 (initiated May 20, 2026) |
| Status | Open, Classified |
| Reason | Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. |
| Root cause | Process design |
| Action | On 03/11/2026, the firm emailed an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that due the fact that the PSA Box Trial cannot be properly assembled with the Hinge Trial in the affected devices because of incomplete processing of the screw components, which may result in interference during assembly with the corresponding device. On 05/20/2026, the firm emailed an updated "URGENT: MEDCIAL DEVICE RECALL" Letter Customers are instructed: 1. Examine your inventory immediately to locate the affected product whose quantities and lot numbers are listed above. Please note th |
| Quantity | 2 |
| Distribution | US Nationwide distribution in the states of Texas and Michigan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.