The Recall Desk

FDA (Devices) recall action 72205

Smith & Nephew, Inc., Endoscopy Div. recalled 4 products on 2015-10-28

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2015-10-28
Critical
0
Units
4,483

Why these products were recalled

Sterility of device is compromised due to breach in the packaging

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.

1–4 of 4

  • HighFDA (Devices)··2015-10-28

    Smith & Nephew MOSAICPLASTY DP Harvesting System Recalled for Packaging Breach

    Smith & Nephew is recalling 1,246 units of the MOSAICPLASTY DP Disposable Harvesting System because a packaging breach compromised the device's sterility.

    Product
    Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile Part Number: 7209237 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-10-28

    Smith & Nephew MOSAICPLASTY DP Harvesting System Recalled for Packaging Breach

    Smith & Nephew is recalling 603 units of the MOSAICPLASTY DP Disposable Harvesting System because a breach in the packaging compromised the device's sterility.

    Product
    Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Part Number: 7209234 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-10-28

    Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System Recalled for Packaging Breach

    Smith & Nephew is recalling 1,347 units of the MOSAICPLASTY DP- Disposable Harvesting System because a packaging breach compromised the device's sterility.

    Product
    Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile Part Number: 7209236 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-10-28

    Smith & Nephew MOSAICPLASTY Harvesting System Recalled for Packaging Breach

    Smith & Nephew is recalling MOSAICPLASTY DP- Disposable Harvesting Systems because a breach in the packaging compromised the device's sterility.

    Product
    Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile Part Number: 7209235 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
    Category
    Distribution
    0 states