Z-2762-2026Class II

SeaSpine Polyaxial Head REF Number: 41-3010

Name: Z-2762-2026 SeaSpine Polyaxial Head REF Number: 41-3010
Creator: Seaspine Orthopedics Corporation
Published: 2026-05-28
License: https://open.fda.gov/license/

SeaSpine Orthopedics Corporation / initiated 2026-05-28 / Open, Classified / root cause: manufacturing process

FDA source

SEASPINE ORTHOPEDICS CORPORATION began a recall of SeaSpine Polyaxial Head REF Number: 41-3010 on 2026-05-28. FDA classified it as Class II and gives the reason as "Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2762-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-28
Posted: 2026-07-20
Recalling firm: SeaSpine Orthopedics Corporation
Product: SeaSpine Polyaxial Head REF Number: 41-3010
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
Root cause tag: manufacturing process
FDA root cause: Process change control
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.
Quantity in commerce: 796 units
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.
Product codes and lots: UDI: 10889981155117; Affected Lots: AW199682G, AW199684G.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2762-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2762-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-20

Product code NKB

K173882Class IISeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation / cleared 2018-02-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)