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Recall Observatory FDA recall evidence

Device product

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.

Z-1296-2014

March 11, 2014

Class II

Product summary

Firm
Teleflex Medical
Event
Event 67733
Status
Terminated
Classification
Class II
Quantity
Total 32,271 ea.
Official record key
device-enforcement:Z-1296-2014

Official wording

Reason: The products are being recalled because they did not meet minimum needle attachment strength requirements.

Code information: Product Code: X-6371M5, Lot numbers: 02E0801603

Distribution pattern: Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The products are being recalled because they did not meet minimum needle attachment strength requirements.