Recall Z-1560-2014 ยท GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Teleflex Medical
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.
| Date | May 7, 2014 (initiated Mar 11, 2014) |
| Status | Terminated |
| Reason | Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use. |
| Root cause | Employee error |
| Action | Urgent Medical Device Recall Notification letters were issued on March 11, 2014 to consignees. The letter requested that customers discontinue use and quarantine any product on hand. The attached Recall Acknowledgment Form should be completed and returned to Teleflex regardless of whether affected product is on hand or not. Once received a customer service representative will contact customers with instructions on how to return the affected product. Questions should be directed to Customer Service at 1-866-246-6990. |
| Quantity | 32,271 ea. |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K930738 | SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC Deknatel, Inc., Jul 26, 1994 |