USTAR II Knee System Recall Issued
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 two units of USTAR II Knee System Hinge Box Trials due to a manufacturing issue 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, medical-device.
What Happened
United Orthopedic Corp. initiated a voluntary recall of specific USTAR II Knee System components after a subcontractor failed to complete processing of the component screw, which prevents proper assembly of the stem trail.
Which Products Are Affected
The recall affects the USTAR II Knee System Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6. Model/catalog numbers include 9325-5711 through 9325-5716 and 9325-5721 through 9325-5726. Affected lot numbers and UDI-DI codes are: 9325-5711 (04719886907032, lot 25FB41), 9325-5712 (04719886907049, lot 25FB42), 9325-5713 (04719886907056, lot 25FB43), 9325-5714 (04719886907063, lot 25FB44), 9325-5715 (04719886907070, lot 25FB45), 9325-5716 (04719886907087, lot 25FB46), 9325-5721 (04719886907094, lot 25FB35), 9325-5722 (04719886907100, lot 25FB36), 9325-5723 (04719886907117, lot 25FB37), 9325-5724 (04719886907124, lot 25FB38), 9325-5725 (04719886907131, lot 25FB39), and 9325-5726 (04719886907148, lot 25FB40). Two units were distributed nationwide in Texas and Michigan. Recall number Z-2884-2026. The products are knee femur prosthesis trials, reusable.
What You Should Do
Consumers should follow instructions provided in the firm's notification letter regarding the recalled devices.
Why This Matters
The recall involves a Class II medical device distributed in limited U.S. states, with the defect affecting proper assembly of the prosthesis trial component.
Source
FDA recall Z-2884-2026, United Orthopedic Corp., initiated May 20, 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 (1,532 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.