FDA Medical Device Recalls (openFDA)
Ebi, Llc: BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system
- Recall number
- Z-0359-2014
- Recalling firm
- Ebi, Llc
- Product
- BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system
- Status
- Terminated
- Initiated
- 2013-08-22
- Posted
- 2013-11-19
- Terminated
- 2016-08-31
- Reason
- Polaris Translation Screw Failures were recently reported to Biomet Spine. These failures are generally described as dissociation of the screw head from the shaft of the Polaris Translation Screw.
- Root cause
- Device Design
- Action
- Urgent Product Information notices dated 8/22/2013 were mailed via FedEx to distributors on 8/23/2013. Follow-up emails with a copy of the UPI notice were sent to distributors on 8/23/2013. The UPI notice informed the customers of the issue with the product and how to identify the affected product. Customers were advised that the Polaris Translation Screw System and the SpF Implantable Spine Fusion Stimulator not be used in conjunction with any implants containing cobalt chrome. Firm contacts were provided in case customers had any questions. EBI, LLC had a conference call with their domestic distributors on 8/23/2013 informing them they are required to notify their customers.
- Quantity
- 7,092 units
- Distribution
- Nationwide distribution including Puerto Rico.
- Lot, serial or model codes
- Multiple Item and Lot numbers. The firm expects all Translation Screw Systems (containing a cobalt chrome component) used and contacted with the SpF Implantable Spine Fusion Stimulator (DC electrical current) to be at risk for this failure mode.
- 510(k) numbers
- ["K123549"]
- PMA numbers
- not on file
- Product code
- HWC
- 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
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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