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.
Reported: March 5, 2014 Initiated: January 23, 2014 #Z-1066-2014
Product Description
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.
Reason for Recall
Inner spherical radius of the shell is undersized.
Details
- Recalling Firm
- Smith & Nephew Inc
- Units Affected
- 10 units
- Distribution
- Worldwide Distribution: US Distribution to NJ and FL; and the countries of: Colombia and Costa Rica.
- Location
- Memphis, TN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Smith & Nephew Inc. Units affected: 10 units.
Why was this product recalled? ▼
Inner spherical radius of the shell is undersized.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 5, 2014. Severity: Moderate. Recall number: Z-1066-2014.
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