FDA Medical Device Recalls (openFDA)
Ebi, Llc: Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178
- Recall number
- Z-0536-2013
- Recalling firm
- Ebi, Llc
- Product
- Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178
- Status
- Terminated
- Initiated
- 2012-09-29
- Posted
- 2012-12-17
- Terminated
- 2015-12-07
- Reason
- Broken screw insertor hardness was measured and found to be below the acceptable limits.
- Root cause
- Process control
- Action
- Biomet mailed Urgent Medical Device Recall Notice/Fax Back Response Form dated 9/25/2012 to the distributors on 9/29/2012.
- Quantity
- 15 units
- Distribution
- Nationwide Distribution, including the states of MO, TX, and IN.
- Lot, serial or model codes
- Lot Numbers 540199, 540199-1
- 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