Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instruments
FDA device recall Z-0909-2015 · posted 2015-01-05 · Terminated
Recall details
- Recalling firm
- Ebi, Llc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 2816 approx.units ( 2688 units US and 128 OUS)
- Distribution
- Worldwide Distribution: US Distribution to states of: AL, CA, CT, IN, LA, NC, NJ TX & WI; and the country of: The Netherlands.
- Date initiated
- 2014-10-08
- Date posted
- 2015-01-05
- Date terminated
- 2015-12-21
- Location
- Parsippany, NJ
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM (K123549) | Biomet Spine (Aka Ebi, LLC) | 2013-02-25 |