SC-AcuFix Thinline Low-Profile Anterior Cervical Plate System manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company, Austin, Texas
- Company
- Spinal Concepts, Inc
- Recall Initiated
- July 1, 2002
- Posted
- June 11, 2005
- Terminated
- December 20, 2005
- Recall Number
- Z-0880-05
- Quantity
- 10 systems
- Firm Location
- Austin, TX
Reason for Recall
Complaints were recieved where swivels came out of plate and where the screw went through the plate.
Distribution
Systems were distributed to hospitals in CA, IL, IN, NC, MS, PA, NY and VA
Lot / Code Info
All devices lot number 10RY and earlier of the following part numbers were removed from the market in 2002: 407-1020; 407-1022; 407-1024; 407-1026; 407-1028; 407-1030; 407-1032; 407-1034; 407-2236; 407-2238; 407-2240; 407-2242; 407-2244; 407-2246; 407-2248; 407-2250; 407-2252; 407-2254
Root Cause
Other
Action Taken
The firm initiated the recall via telephone communication from sales representatives around August 2002.
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