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.
FDA Recall Z-1296-2014 · Posted 2014-03-26
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Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeGAT
Date Initiated2014-03-11
Date Terminated2017-08-15
Product QuantityTotal 32,271 ea.
Reason for Recall
The products are being recalled because they did not meet minimum needle attachment strength requirements.
Firm Action
Teleflex sent an Urgent Medical Device Recall Notification letter dated March 11, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to return all affected product to Teleflex Medical per the instructions provided in the letter. Customers were asked to complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service. For questions contact your local sales representative or Customer Service at 1-866-246-6990
Root Cause
Employee error
Distribution Pattern
Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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