FDA Recall of Orthalign Drill Plate Due to Manufacturing Issue
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Orthalign, Inc. is recalling 7 units of a medical device due to manufacturing defects that could result in excessive bone cuts.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 7, 2026 and geographically references United States. 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
Orthalign, Inc. is recalling the Drill Plate because it was manufactured out of specification, which can result in a bone cut in excess of 0.0800 inches (2.8448 mm).
Which Products Are Affected
The affected product is the Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component of the Lantern Knee System. The recall involves 7 units with Lot # 25092204BB and UDI:00810832032434. Distribution was US Nationwide in the state of UT.
What You Should Do
Consumers should follow the initial firm notification, which was a letter, and contact Orthalign, Inc. for further instructions regarding the recall.
Why This Matters
This recall addresses a potential risk of injury from improper bone cuts during medical procedures, highlighting the importance of precise manufacturing in medical devices to ensure patient safety.
Source
Attribution: FDA Recall Number Z-1630-2026. For more information, visit the FDA website at https://www.fda.gov/medical-devices/medical-device-recalls.
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 (1,020 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.