Recall Z-1066-2014— Smith & Nephew Inc

Name: FDA recall Z-1066-2014
Creator: U.S. Food and Drug Administration
Published: 2014-01-23

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew Inc, initiated 2014-01-23, terminated 2016-11-15. It names one FDA 510(k) clearance: K960094. 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.. Reason: Inner spherical radius of the shell is undersized..

Recalling firm: Smith & Nephew Inc
Classification: Class II
Status: Terminated
Initiated: 2014-01-23
Terminated: 2016-11-15
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K960094 — REFLECTION DUAL DIMENSION SHELLSmith & Nephew Richards, Inc.·cleared 1996-03-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.