Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 3, 2016
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
The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Smith & Nephew, Inc. recalled SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, … - a moderate-severity action.
SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, … was recalled by Smith & Nephew, Inc. in August 3, 2016. Reason: The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm scre…. Check the official notice for the remedy. Verify recall #Z-2297-2016 with the FDA Devices before acting.
The recall
Smith & Nephew, Inc. issued this moderate-severity FDA Devices recall-The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm scre….
- Moderate
- severity level
- 185 units
- affected scope
- Class II
- classification
- August 3, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2297-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2297-2016) was formally reported on August 3, 2016, with the manufacturer initiating the action on July 6, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Smith & Nephew, Inc. is listed as the recalling firm, operating out of Memphis, TN. Federal records list the affected scope as 185 units.
The documented reason for this recall is: The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw. Distribution data in the federal record shows the product reached: Worldwide Distribution - US (nationwide) and Internationally to AU, CA, GB, IN, ZA, and TR. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
185 units
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2297-2016 |
| Date reported | August 3, 2016 |
| Date initiated | July 6, 2016 |
| Recalling firm | Smith & Nephew, Inc. |
| Firm location | Memphis, TN |
| Affected scope | 185 units |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to AU, CA, GB, IN, ZA, and TR |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2297-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Smith & Nephew, Inc.. Units affected: 185 units.
Why was this product recalled? ▼
The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 3, 2016. Severity: Moderate. Recall number: Z-2297-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US (nationwide) and Internationally to AU, CA, GB, IN, ZA, and TR.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2297-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 3, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.