Device product
Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture, Sterile, Rx Only, Teleflex Medical. Indicated for use in soft tissue approximation.
Z-1558-2014
Product summary
- Firm
- Teleflex Medical
- Event
- Event 67711
- Status
- Terminated
- Classification
- Class II
- Quantity
- 32,271 ea.
- Official record key
device-enforcement:Z-1558-2014
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 BON100 - Lot 02H1302839, 02J1101705, 02D1101137, 02F1103013, Product Code EP4049N - Lot 02A1003137
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.