FDA-Device2014-04-02Class II
Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural non-absorbable silk surgical suture is a non-absorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Natural non-absorbable silk surgical suture is indicated for use in soft tissue approximation. Natural non-absorbable silk surgical suture meets the United States Pharmacopeia (U
Teleflex Medical
Hazard
The products are being recalled because they did not meet minimum needle attachment strength requirements.
Sold states
Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland
Affected count
Total 32,271 ea.
Manufactured in
2917 Weck Dr., N/A, Research Triangle Park, NC, United States
Products
Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural non-absorbable silk surgical suture is a non-absorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Natural non-absorbable silk surgical suture is indicated for use in soft tissue approximation. Natural non-absorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Non-absorbable Surgical Suture (class I). Natural non-absorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1296-2014Don't want to check this manually?
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