Summary
The FDA issued a Class II for SeaSpine Polyaxial Head REF Number: 41-3010 by SEASPINE ORTHOPEDICS CORPORATION. Reason: Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion..
Details
Source
Device Recall
External ID
Z-2762-2026
Action Date
2026-07-29
Status
Ongoing
Category
device
Product Description
SeaSpine Polyaxial Head REF Number: 41-3010
Lot/Code Info: UDI: 10889981155117; Affected Lots: AW199682G, AW199684G.
Quantity Affected: 796 units
Reason for Recall
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-28
Company
Carlsbad, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 154 device recalls issued in the same week, part of 373 device-related FDA actions this month.
SEASPINE ORTHOPEDICS CORPORATION has 32 FDA actions in our database, including 10 recalls and 22 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SEASPINE ORTHOPEDICS CORPORATION) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SEASPINE ORTHOPEDICS CORPORATION have FDA actions?
SEASPINE ORTHOPEDICS CORPORATION has 32 FDA actions in our database, including 10 recalls and 22 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2762-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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