Reflection Interfit Shell — Class II medical device recall Z-1066-2014
Terminated recall by Smith & Nephew Inc, reported 2014-03-05, distributed in FL, NJ. Inner spherical radius of the shell is undersized.
| Recall number | Z-1066-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew Inc, Memphis, TN, United States |
| Recall initiated | 2014-01-23 |
| Classified | 2014-02-21 |
| Reported by FDA | 2014-03-05 |
| Terminated | 2016-11-15 |
| Distributed | FL, NJ |
| Countries outside the US | CO, CR |
| Quantity | 10 units |
| Lot numbers | 13EM03053 |
| Model numbers | 71336052 |
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 for recall
Inner spherical radius of the shell is undersized.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1066-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.