U2 Total Knee System Femoral Valgus 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. recalls two units of U2 Total Knee System femoral valgus 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 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, MedicalDevices.
What Happened
United Orthopedic Corp. initiated a voluntary recall due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Which Products Are Affected
Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 UDI-DI Codes: 04719886908084 (9323-5333) and 04719886908091 (9323-5334) Lot numbers: 25FB50 (9323-5333) and 25FB51 (9323-5334) Quantity: 2 units Recall Number: Z-2885-2026 Distribution: US Nationwide in Texas and Michigan
What You Should Do
Consumers should verify products against the listed model, lot numbers, and UDI-DI codes and contact the recalling firm regarding the recall.
Why This Matters
This Class II recall affects a limited number of orthopedic surgical instruments distributed in two states.
Source
FDA recall Z-2885-2026, United Orthopedic Corp., Kaohsiung, Taiwan.
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 (953 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.