U2 Total Knee System Tibial Insert — Class II medical device recall Z-1129-2018
Terminated recall by United Orthopedic Corporation, reported 2018-03-28. UOC received a customer compliant report from our distributor on October 31, 2017 which stated that contents o
| Recall number | Z-1129-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | United Orthopedic Corporation, Hsinchu, N/A, Taiwan |
| Recall initiated | 2017-11-24 |
| Classified | 2018-03-19 |
| Reported by FDA | 2018-03-28 |
| Terminated | 2018-10-09 |
| Countries outside the US | CH, CN, FR, GB, GR, IR, IT, KR, PK, TW, ZA |
| Quantity | 14 units |
| Reason classes | labeling |
| Lot numbers | 17B621AG |
| Model numbers | 2303-5016 |
Product
U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016 The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee cannot be satisfactorily balanced and stabilized at the time of surgery.
Reason for recall
UOC received a customer compliant report from our distributor on October 31, 2017 which stated that contents of the package do not match the product labeling.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1129-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.