U2 Total Knee System Femoral Offset Bushing Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
United Orthopedic Corp. is recalling 3 units of the U2 Total Knee System femoral offset bushing due to a design issue with engraved numbering.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 20, 2026 and geographically references Texas and Michigan. 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. initiated a voluntary recall due to a design issue causing incorrect engraved numbering on the implant that could result in the incorrect orientation of the implant.
Which Products Are Affected
The recall affects the Brand Name: U2 Total Knee System, Product Name: Femoral offset bushing, 2mm and 6mm. Model/Catalog Number: 9323-5312. Lot Code: Product number 9323-5312; UDI-DI 04719886908077; Lot number 25FC64. A total of 3 units were distributed in the states of Texas and Michigan.
What You Should Do
Consumers should contact the recalling firm for further information regarding the recall.
Why This Matters
The recall involves a Class II medical device distributed in two U.S. states and is classified as ongoing.
Source
FDA recall number Z-2898-2026
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 (812 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 20, 2026.
Frequently Asked Questions
Common questions about this FDA recall.