FDA Medical Device Recalls (openFDA)
SEASPINE ORTHOPEDICS CORPORATION: SeaSpine Polyaxial Head REF Number: 41-3010
- Recall number
- Z-2762-2026
- Recalling firm
- SEASPINE ORTHOPEDICS CORPORATION
- Product
- SeaSpine Polyaxial Head REF Number: 41-3010
- Status
- Open, Classified
- Initiated
- 2026-05-28
- Posted
- 2026-07-20
- Terminated
- not on file
- Reason
- Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
- 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
- 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.
- Lot, serial or model codes
- UDI: 10889981155117; Affected Lots: AW199682G, AW199684G.
- 510(k) numbers
- ["K173882"]
- PMA numbers
- not on file
- Product code
- NKB
- Firm FEI
- 3012120772
- Firm city
- Carlsbad
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28