FDA Device recall Z-1066-2014
Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc
- FDA Device
- Class II
- terminated
- Published 2014-03-05
On 2014-03-05 the FDA classified a Class II recall of Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc by Smith And Nephew, citing inner spherical radius of the shell is undersized.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1066-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-01-23 |
| Published | 2014-03-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Smith And Nephew |
| Distribution | FL, NJ |
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.
Identifiers
| code_info | Batch No. 13EM03053 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1066-2014%22
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