Device product
Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Suture, U.S.P. Used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
Z-1560-2014
Product summary
- Firm
- Teleflex Medical
- Event
- Event 67711
- Status
- Terminated
- Classification
- Class II
- Quantity
- 32,271 ea.
- Official record key
device-enforcement:Z-1560-2014
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 X-4981M4 - Lot 02J0800451
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.