FDA Medical Device Recalls (openFDA)
Ebi, Llc: Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device.
- Recall number
- Z-0954-2013
- Recalling firm
- Ebi, Llc
- Product
- Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device.
- Status
- Terminated
- Initiated
- 2013-02-07
- Posted
- 2013-03-15
- Terminated
- 2015-12-07
- Reason
- Increased risk of failure at the driver tip during screw insertion or removal.
- Root cause
- Process control
- Action
- Biomet Spine sent a "Urgent Medical Device Recall" notices dated February 6, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately locate and remove affected items from circulation and return affected product to EBI, LLC. Please follow the instructions on the enclosed "FAX Back Response Form, " and fax a copy of the Response Form to (973) 257-0232, prior to return of the items. Questions related to this notice should be directed to (973) 299-9300 ex. 2322. Monday through Friday, 8am to 5pm.
- Quantity
- 59 units.
- Distribution
- Nationwide Distribution including the states of AL, IN, MO, NE TN and TX.
- Lot, serial or model codes
- Catalog Number 14-500178. Lot numbers: 543619, 543853, 543853-1, 543853-2, 544233, 544234-1, 546613 and 546613-1.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HXX
- Firm FEI
- 2242816
- Firm city
- Parsippany
- Firm state
- NJ
- 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