SPHERICAL HEAD REFLECTION — Class II medical device recall Z-2297-2016
Terminated recall by Smith & Nephew, Inc., reported 2016-08-03, distributed nationwide. The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw
| Recall number | Z-2297-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2016-07-06 |
| Classified | 2016-07-28 |
| Reported by FDA | 2016-08-03 |
| Terminated | 2017-07-01 |
| Distributed | Nationwide (US) |
| Quantity | 185 units |
| Reason classes | labeling |
| Lot numbers | 16AM14274 |
| Model numbers | 71332525 |
Product
SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total hip components are indicated for individuals undergoing primary or revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant; congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
Reason for recall
The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw.
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-2297-2016. 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.