The Recall Desk

FDA (Devices) recall action 62617

Smith & Nephew, Inc. Endoscopy Division recalled 2 products on 2012-08-15

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2012-08-15
Critical
0
Units
448

Why these products were recalled

Device labeled with an expiry period of 48 months instead of 36 months; an additional 12 months for which product and package reliability has not been validated.

Devices labeled with an expiry period of 48 months instead of 36 months; an additional 12 months for which product and package reliability has not been validated.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··2012-08-15

    Smith & Nephew Dyonics Bonecutter Recalled for Incorrect Expiry Labeling

    Smith & Nephew is recalling 108 units of the 5.5 mm Dyonics Bonecutter because the devices are labeled with a 48-month expiry instead of the validated 36-month period.

    Product
    Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade Full Radius Part Number: 7205962 Product Usage: The Dyonics Electroblade Resector is indicated for use in arthroscopic surgical procedures of large and small articular cavities. The Dyonics Electroblade Resector is…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2012-08-15

    Smith & Nephew Dyonics Electroblade Resector Recalled for Labeling Error

    Smith & Nephew is recalling Dyonics Electroblade Resectors labeled with an incorrect 48-month expiry date instead of 36 months.

    Product
    Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECUTTER Part Number: 72202213 Product Usage: The Dyonics Electroblade Resector is indicated for use in arthroscopic surgical procedures of large and small articular cavities. The Dyonics Electroblade…
    Category
    Distribution
    0 states