FDAJanuary 3, 2024device
USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: REF: PE25153109 - 9x125mm, PE25153209 - 9x150mm, PE25153113 - 13x125mm, PE25153111- 11x125mm, PE25153115 - 15x125mm, PE25153211 - 11x150mm, PE25153213 - 13x150mm, PE25153217 - 17x150mm, PE25153117 - 17...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Their is a potential that the implant curved stem may be oriented incorrectly.
What to do
FDA enforcement status: Ongoing
Brands named
united orthopedicunited
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDASalt2026-05-14
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- 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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