SeaSpine Polyaxial Head REF Number: 41-3010
FDA Recall Z-2762-2026 · Posted 2026-07-20
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Recalling FirmSEASPINE ORTHOPEDICS CORPORATION
Recall StatusOpen, Classified
Product CodeNKB
Date Initiated2026-05-28
Product Quantity796 units
Reason for Recall
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
Firm Action
On June 16, 2026, Orthofix issued a updated Urgent Medical Device Recall notification to provide additional information concerning the recall. Initial notification was issued on May 28, 206. Orthofix ask consignees to take the following actions:
1. Discontinue use of affected lots, 2.Immediately identify and quarantine any affected product. 3. If product is identified, Orthofix will facilitate the return. 4. Complete and return the attached Acknowledgement and Receipt Form. 5. This recall notice should be shared with anyone who needs to be aware within your organization and forwarded to any organization where potentially affected devices have been transferred.
Root Cause
Process change control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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