Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixatio

FDA device recall Z-2214-2013 · posted 2013-09-17 · Terminated

Recall details

Recalling firm

Ebi, Llc

Reason for recall

Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

LXH

Quantity affected

427 units

Distribution

Nationwide Distribution (US), including the states of IN, MD, MS, NC, OH, PA, SC, and TX.

Date initiated

2013-08-13

Date posted

2013-09-17

Date terminated

2015-03-11

Location

Parsippany, NJ