FDA Medical Device Recalls (openFDA)
Ebi, Llc: Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.
- Recall number
- Z-1811-2014
- Recalling firm
- Ebi, Llc
- Product
- Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.
- Status
- Terminated
- Initiated
- 2014-05-15
- Posted
- 2014-06-17
- Terminated
- 2017-04-21
- Reason
- The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure.
- Root cause
- Nonconforming Material/Component
- Action
- Biomet sent an "Urgent Medical Device Recall Notice"/Fax Back Response Form dated May 15, 2014, via Fed Ex to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory for the affected product and if located to remove the product from circulation; follow instructions on the attached Fax Back Response Form prior to return of the product; and return the product using the Fed Ex label included with the notification. Customers were instructed, if if they further distributed the product, they must notify their customers of the recall via the enclosed "Dear O.R. Manger" notice. If the customers had any questions they were asked to please contact Biomet, Monday through Friday (8 am to 5 pm) at 973.299.9300 xt. 2322.
- Quantity
- 32 units (30 domestic and 2 international)
- Distribution
- Worldwide Distribution - USA (nationwide) and the country The Netherlands.
- Lot, serial or model codes
- Catalog Number 14-501669; Lot Number 006731
- 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