SeaSpine Polyaxial Head 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.
SEASPINE ORTHOPEDICS CORPORATION is recalling 796 units of SeaSpine Polyaxial Head REF 41-3010 due to a manufacturing error that may cause the head to detach from the screw during surgery.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 12, 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, Medical Devices.
What Happened
SEASPINE ORTHOPEDICS CORPORATION is recalling SeaSpine Polyaxial Head devices because of a manufacturing error where the polyaxial head may pop off from the screw intraoperatively following insertion.
Which Products Are Affected
The recall affects 796 units of SeaSpine Polyaxial Head, REF Number: 41-3010. Affected lots are AW199682G and AW199684G. UDI is 10889981155117. Distribution includes US nationwide in Alabama, Arizona, California, Colorado, Connecticut, Florida, Illinois, Indiana, Kansas, Maryland, Michigan, Missouri, Mississippi, Montana, Nevada, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, and Wyoming, plus Chile and Australia.
What You Should Do
Consumers and healthcare providers should follow the recalling firm's instructions for returns or further actions regarding the affected devices.
Why This Matters
The recall involves a Class II device distributed worldwide, addressing a potential intraoperative issue with spinal implant components.
Source
FDA recall number Z-2762-2026, Event ID 99221.
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 (1,097 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 12, 2026.
Frequently Asked Questions
Common questions about this FDA recall.