openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 2
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, 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.
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
Lot number 17B621AX
Distribution pattern
Worldwide Distribution - US Distribution and to the countries of: UK, Iran, Greece, Pakistan, Switzerland, France, China, Taiwan, Italy, Korea and South Africa.
device · product 2 of 2
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.
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
Lot number 17B621AG
Distribution pattern
Worldwide Distribution - US Distribution and to the countries of: UK, Iran, Greece, Pakistan, Switzerland, France, China, Taiwan, Italy, Korea and South Africa.
