Smith & Nephew Recalls Spherical Head Reflection Cancellous Screws Due to Labeling Error
Smith & Nephew is recalling 185 units of Spherical Head Reflection 6.5 mm Cancellous Screws because the packaging contained 35mm screws instead of the labeled 25mm size.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error where the physical product size did not match the label, which fits the criteria for moderate severity involving minor labeling errors or low-risk contamination.
Plain-English summary
Smith & Nephew, Inc. is recalling 185 units of Spherical Head Reflection 6.5 mm Cancellous Screws, Reference 71332525, Lot Number 16AM14274. The recall was initiated because the product labels correctly stated that the box should contain a 25mm screw, but the boxes actually contained longer, 35mm screws.
The affected products were distributed worldwide, including nationwide in the United States and internationally to Australia, Canada, the United Kingdom, India, South Africa, and Turkey. These total hip components are indicated for individuals undergoing primary or revision surgery for various hip conditions.
Healthcare providers and patients should stop using the affected screws and contact Smith & Nephew for further instructions. The recall is classified as Class II by the FDA, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- 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 resul
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- Affected units
- 185
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number 16AM14274
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Smith & Nephew, Inc.
See all →- HighTRIGEN proximal humeral nails are missing their distal holes
FDA (Devices) · 2026-06-24
- ModerateBone fixation screws recalled over a labeling error on one lot
FDA (Devices) · 2025-12-24
- ModerateSmith & Nephew Lag/Compression Screw Kit Undersized Socket Defect
FDA (Devices) · 2025-05-28
- HighBIORAPTOR Suture Anchors Recalled for Sterile Barrier Packaging Breach
FDA (Devices) · 2024-12-11
- HighSmith & Nephew Bipolar Hip Implant Component Recalled for Oversized Retainer Ring
FDA (Devices) · 2024-11-13
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02