FDA Issues Recall for Orthalign Drill Plate Due to Manufacturing Defect
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
The FDA has announced a recall of 7 units of Orthalign's Drill Plate due to manufacturing issues that could lead to excessive bone cuts during surgery.
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
The FDA has initiated a recall because the Drill Plates were 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 1-5 REF:402566 component of the Lantern Knee System. The recall involves 7 units with Lot # 25091103BB and UDI: 00810832032427. The recall number is Z-1629-2026, and distribution was US Nationwide, including the state of UT.
What You Should Do
Consumers who have the affected product should contact the recalling firm, Orthalign, Inc, at their address: 120 Columbia Ste 500, Aliso Viejo, CA 92656-4107, as the initial notification was made via letter for further instructions on returns or refunds.
Why This Matters
This recall highlights potential risks in medical devices that could affect surgical procedures, emphasizing the need for precise manufacturing to ensure patient safety.
Source
This information is from the FDA recall notice, available at the FDA website under recall number Z-1629-2026.
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 (1,109 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.