Recall Z-2897-2026 ยท LWH Counter, Sponge, Surgical
United Orthopedic Corp.
Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A
| Date | Aug 6, 2026 (initiated Mar 19, 2026) |
| Status | Open, Classified |
| Reason | Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant. |
| Root cause | Device Design |
| Action | On 03/09/2026, the firm distributed an "URGENT: MEDICAL DEVICE RECALL" Letter informing customer that due the fact that the Femoral offset bushing in the affected devices is engraved with the incorrect numbering, and the rotational direction does not align with the intended orientation. Customers are instructed to: 1. Examine inventory immediately to locate the affected product whose quantities and lot numbers are listed in the letter. Note the product may have already been returned. 2. Cease all use of these devices immediately and quarantine all affected devices in their territory for imm |
| Quantity | 3 |
| 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.