Device product
Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc. Indications for use include cemented or uncemented total hip arthroplasty for rheumatoid arthritis; osteoarthritis; post traumatic arthritis, avascular necrosis; femoral and neck fractures; osteomyelitis; fracture, dislocation of the hip; and unsuccessful cup arthroplasty, endoprosthesis, femoral osteotomy, or girdlestone resection.
Z-1066-2014
Product summary
- Event
- Event 67404
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 units
- Official record key
device-enforcement:Z-1066-2014
Official wording
Reason: Inner spherical radius of the shell is undersized.
Code information: Batch No. 13EM03053
Distribution pattern: Worldwide Distribution: US Distribution to NJ and FL; and the countries of: Colombia and Costa Rica.
Derived failure modes
-
Unknown
Inner spherical radius of the shell is undersized.