FDANovember 24, 2017device
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 arthriti...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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 to do
FDA enforcement status: Terminated
Brands named
united orthopedicunited
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAGreat Value Hawaiian Roll 4pk, Item # F63384. Product is perishable dinner roll ready to eat, sold in a corrugated case of 18 packages (4.5oz net wt.) individually wrapped in laminated film. This product was never sold in stores and was never available for consumer purchase. All affected product ...2026-05-15
- FDASalt2026-05-14
- FDACleansing Towelette (Benzalkonium Chloride 0.13%), 5"x 7", 1,000 case/Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0243-00.2026-01-20
- FDASavannah Antibacterial Towelettes (Benzalkonium Chloride 0.13%), 1 towelette, 4 x 7, R&R Enterprise, NDC 59647-749-022026-01-20
- FDAFirst Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 50 Wipes, NDC 0924-7116-03.2026-01-20
- FDAMedi-First Antiseptic Wipes (BZK)(Benzalkonium Chloride 0.13%), 100 wipes per box, Manufactured for Medique Products, Fort Meyers, FL, 33967, NDC 47682-122-33.2026-01-20
- FDADynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 packets, 5" x 7", Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA Made in USA, NDC 67777-244-022026-01-20
- FDAHand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 1000 per case, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC 27801, NDC 0924-0301-002026-01-20
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