CLASS II ONGOING Device recall · Reported 29 Jul 2026 · FDA Enforcement Report
SeaSpine Polyaxial Head recalled by Seaspine Orthopedics
Seaspine Orthopedics is recalling SeaSpine Polyaxial Head, distributed nationwide in the US. The recall was initiated on 28 May 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2762-2026
- FDA event ID
- 99221
- Recalling firm
- Seaspine Orthopedics, Carlsbad, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 May 2026
- FDA classified
- 20 Jul 2026
- Reported
- 29 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 28 May 2026 | Recall initiated by company | |
| 20 Jul 2026 | Classified by FDA | +53 days |
| 29 Jul 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
Product as listed by the FDA
SeaSpine Polyaxial Head REF Number: 41-3010
Where it was distributed
Worldwide - US Nationwide distribution including in the states of 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. The countries of Chile and Australia.
Nationwide AlabamaArizonaCaliforniaColoradoConnecticutFloridaIllinoisIndianaKansasMarylandMichiganMissouriMississippiMontanaNevadaOhioOklahomaSouth CarolinaSouth DakotaTennessee
Questions about this recall
Is SeaSpine Polyaxial Head recalled?
Yes. Seaspine Orthopedics recalled SeaSpine Polyaxial Head on 28 May 2026. The recall is Class II and its status is Ongoing. Recall number Z-2762-2026.
Why was it recalled?
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
Which lots are affected?
UDI: 10889981155117; Affected Lots: AW199682G, AW199684G.
Where was it sold?
Worldwide - US Nationwide distribution including in the states of 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. The countries of Chile and Australia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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