⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

SEASPINE ORTHOPEDICS CORPORATION: SeaSpine Polyaxial Head REF Number: 41-3010

Medical DevicesSource: FDA (device) · Date: 2026-07-29

Read the official notice at FDA (device) →

Share on XFacebookRedditEmail

Get alerts for Seaspine Orthopedics

Guides: Which agency handles which recall (FDA vs USDA vs CPSC vs NHTSA)

The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
SEASPINE ORTHOPEDICS CORPORATION
Product
SeaSpine Polyaxial Head REF Number: 41-3010
Reason / hazard
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2026-05-28
Code info
UDI: 10889981155117; Affected Lots: AW199682G, AW199684G.
Product quantity
796 units
Voluntary mandated
Voluntary: Firm initiated
City
Carlsbad
State
CA
Country
United States
Event id
99221
Free daily digest + "My products" watchlist

Get the daily digest, and tell us what to watch. Everything is optional except your email.

Free allergen alerts:

Categories:

Privacy: we store only what you enter here, use it only to send recall alerts you asked for, never sell or share it, and you can unsubscribe anytime. Double opt-in: we will email you a confirmation link before sending anything; alerts start only after you confirm. Every email has unsubscribe and manage-watchlist links.