United Orthopedic Corp. Recalls U2 Total Knee System Femoral Offset Bushing
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 that could lead to incorrect implant orientation.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 18, 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 of the U2 Total Knee System Femoral offset bushing 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, 0mm and 4mm, Model/Catalog Number: 9323-5310. It involves 3 units distributed nationwide in the states of Texas and Michigan under Lot number 25FC58 (UDI-DI 04719886908060). The recall number is Z-2897-2026.
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 in the US that may result in incorrect implant orientation.
Source FDA recall Z-2897-2026, United Orthopedic Corp., ongoing as of report date 20260812.
Original source: FDA Official Notice ↗
Related FDA Recalls
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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 (967 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 18, 2026.
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