Food, drugs, devices › United Orthopedic Corporation
Device recall: U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Catalogue number 2303-3032 The U2 Total Knee sy
FDA enforcement event 79321 is a device recall by United Orthopedic Corporation of Hsinchu, N/A, initiated 24 Nov 2017 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 9 Oct 2018. Initiation: voluntary: firm initiated. United Orthopedic Corporation has 3 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
United Orthopedic Corporation, Hsinchu, N/A, Taiwan.
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."
Distribution
"Worldwide Distribution - US Distribution and to the countries of: UK, Iran, Greece, Pakistan, Switzerland, France, China, Taiwan, Italy, Korea and South Africa."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1128-2018 | U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Catalogue number 2303-3032 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,… | 69 pieces | Class II | Terminated | 28 Mar 2018 |
| Z-1129-2018 | 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,… | 14 pieces | Class II | Terminated | 28 Mar 2018 |
Context
Other enforcement events for United Orthopedic Corporation
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 3 Jan 2024 | USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: REF: PE11151211 - 11 | Device | Class II | 3 |
| 10 Feb 2017 | UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery t | Device | Class II | 1 |
All 3 events for United Orthopedic Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US Distribution and to the countries of: UK, Iran, Greece, Pakistan, Switzerland, France, China, Taiwan, Italy, Korea and South Africa."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 9 Oct 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.