FDA Medical Device Recalls (openFDA)
Spinal Elements, Inc: Mercury Spinal System DIA 5.5 x 110mm Straight Rod, Part Number: 60101-110. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
- Recall number
- Z-1264-2013
- Recalling firm
- Spinal Elements, Inc
- Product
- Mercury Spinal System DIA 5.5 x 110mm Straight Rod, Part Number: 60101-110. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
- Status
- Terminated
- Initiated
- 2009-04-17
- Posted
- 2013-05-07
- Terminated
- 2013-05-07
- Reason
- Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
- Root cause
- Nonconforming Material/Component
- Action
- Spinal Elements sent Urgent Medical Device Recall notification letters to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the Chief Technology Officer at Spinal Elements for questions about the recall letter.
- Quantity
- 68 units total
- Distribution
- Distributed in OH and PA.
- Lot, serial or model codes
- Lot Number: 080600
- 510(k) numbers
- ["K071914"]
- PMA numbers
- not on file
- Product code
- NKB
- Firm FEI
- 3004893332
- 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