Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instruments are also available for use by the surgeon to facilitate implantation of the device. Non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion.
FDA Recall Z-0909-2015 · Posted 2015-01-05
Advertisement
Recalling FirmEbi, Llc
Recall StatusTerminated
Product CodeNKB
Date Initiated2014-10-08
Date Terminated2015-12-21
Product Quantity2816 approx.units ( 2688 units US and 128 OUS)
Reason for Recall
Inoperative screw head seat splay and/or fracture as a result of positioning of the rod which is a part of the Cypher MIS Screw System.
Firm Action
The firm, EBI LLC/Biomet, sent an "URGENT PRODUCT INFORMATION" letter dated 10/6/2014 via Fed Ex to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to follow the steps outlined in the letter.
If you have any questions, please feel free to contact Director of Regulatory Affairs at 303-501-8548.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution: US Distribution to states of: AL, CA, CT, IN, LA, NC, NJ TX & WI; and the country of: The Netherlands.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement