U2 Total Knee System PSA Box Trial Recall
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United Orthopedic Corp. has initiated a Class II recall of two U2 Total Knee System PSA Box Trial units due to an incomplete component screw process preventing proper stem trial assembly.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 18, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
United Orthopedic Corp. is recalling the U2 Total Knee System PSA Box Trial products because an incomplete process of the component screw by a subcontractor prevents the proper assembling of stem trial.
Which Products Are Affected
The recall affects Brand Name: U2 Total Knee System, Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6. Model/Catalog Numbers: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526. Two units are affected with the following lot codes and UDI-DI codes: 9323-5511 (UDI-DI 04719886906929, Lot 25FB54); 9323-5512 (UDI-DI 04719886906936, Lot 25FB55); 9323-5513 (UDI-DI 04719886906943, Lot 25FB56); 9323-5514 (UDI-DI 04719886906950, Lot 25FB57); 9323-5515 (UDI-DI 04719886906967, Lot 25FB58); 9323-5516 (UDI-DI 04719886906424, Lot 25FB59); 9323-5521 (UDI-DI 04719886906974, Lot 25FB29); 9323-5522 (UDI-DI 04719886906981, Lot 25FB30); 9323-5523 (UDI-DI 04719886906998, Lot 25FB31); 9323-5524 (UDI-DI 04719886907001, Lot 25FB32); 9323-5525 (UDI-DI 04719886907018, Lot 25FB33); 9323-5526 (UDI-DI 04719886907025, Lot 25FB34). Distribution was to Texas and Michigan.
What You Should Do
Consumers in possession of the affected products should follow instructions provided in the firm's notification letter.
Why This Matters
The recall involves a Class II device distributed nationwide in limited quantities that may not assemble properly.
Source
FDA recall number Z-2883-2026, report date 20260812.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,464 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 18, 2026.
Frequently Asked Questions
Common questions about this FDA recall.