U2 Total Knee System Femoral Valgus Offset Adaptor 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. has initiated a Class II recall of six models of femoral valgus offset adaptors due to incomplete screw processing preventing proper assembly.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 19, 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. is recalling certain femoral valgus offset adaptors because an incomplete process of the component screw by a subcontractor prevents proper assembly of the stem trail.
Which Products Are Affected
The recall affects the U2 Total Knee System Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left (model/catalog numbers 9323-5335, 9323-5337, 9323-5339) and right (9323-5336, 9323-5338, 9323-5340). Affected lot numbers are 25FB64, 25FB48, 25FB52, 25FB65, 25FB49, and 25FB53. A total of 2 units were distributed.
What You Should Do
Consumers should follow instructions provided in the firm's notification letter regarding the affected devices.
Why This Matters
The recall involves manual orthopedic surgical instruments distributed to Texas and Michigan.
Source
FDA recall number Z-2886-2026
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 (841 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 19, 2026.
Frequently Asked Questions
Common questions about this FDA recall.