Seaspine Orthopedics Corporation: Thoracolumbosacral Pedicle Screw System
Recall Summary SeaSpine Orthopedics is recalling its Polyaxial Head pedicle screws (model 41-3010) used in spine surgery due to a manufacturing defect that can cause the head to separate from the screw during surgery. The recall affects devices distributed nationwide across the United States, as well as in Chile and Australia. This is classified as a Class II recall, meaning the defect could cause serious health consequences.
- Recalling firm
- SEASPINE ORTHOPEDICS CORPORATION
- Product
- SeaSpine Polyaxial Head REF Number: 41-3010
- Reason
- Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-28
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/753967da-89d7-48a5-bf06-1f9a7c47b883