FDA Medical Device Recalls (openFDA)
Ebi, Llc: Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixation device. 1)Screw Tower - REF 14-501660 2) Rod Reduce - REF 14-501661 3) Counter Torque - REF 14-501662
- Recall number
- Z-2214-2013
- Recalling firm
- Ebi, Llc
- Product
- Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixation device. 1)Screw Tower - REF 14-501660 2) Rod Reduce - REF 14-501661 3) Counter Torque - REF 14-501662
- Status
- Terminated
- Initiated
- 2013-08-13
- Posted
- 2013-09-17
- Terminated
- 2015-03-11
- Reason
- Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.
- Root cause
- Device Design
- Action
- Biomet Spine & Bone Healing Technologies sent "Urgent Medical Device Recall Notice" letters with Fax-Back Response Forms dated 8/13/2013 to distributors and OR managers via Fed Ex. Follow-up e-mails with a copy of the Recall Notice were sent to distributors on 8/13/2013. Customers with questions may contact 973-299-9300 x2162 Monday to Friday from 8:00 am to 5:00 pm EST.
- Quantity
- 427 units
- Distribution
- Nationwide Distribution (US), including the states of IN, MD, MS, NC, OH, PA, SC, and TX.
- Lot, serial or model codes
- 14-501660 Screw Tower Lots IT0024 IT0025 IT0026 IT0027 IT0028 IT0029 14-501661 Rod Reducer Lots IT0015 IT0022 IT0023 14-501662 Counter Torque Lots IT0020 IT0021
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- 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