Date Initiated by Firm | August 13, 2013 |
Date Posted | September 17, 2013 |
Recall Status1 |
Terminated 3 on March 11, 2015 |
Recall Number | Z-2214-2013 |
Recall Event ID |
66098 |
Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
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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 |
Code Information |
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 |
Recalling Firm/ Manufacturer |
Ebi, Llc 100 Interpace Pkwy Parsippany NJ 07054-1149
|
For Additional Information Contact | Ms. Danielle Wernikowski 904-741-4400 |
Manufacturer Reason for Recall | Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System. |
FDA Determined Cause 2 | 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 in Commerce | 427 units |
Distribution | Nationwide Distribution (US), including the states of IN, MD, MS, NC, OH, PA, SC, and TX. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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