Device product
Nonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize, Deknatel. Indicated for use in soft tissue approximation.
Z-1555-2014
Product summary
- Firm
- Teleflex Medical
- Event
- Event 67711
- Status
- Terminated
- Classification
- Class II
- Quantity
- 32,271 ea.
- Official record key
device-enforcement:Z-1555-2014
Official wording
Reason: Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
Code information: Product Code 1154654 - Lot 02K0801212
Distribution pattern: Worldwide Distribution -- USA, including the states of AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI; and countries of Canada, Germany, and Ireland.
Derived failure modes
-
Unknown
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.