Recall Z-1535-2014 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Teleflex Medical
Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture USP, Rx Only, Sterile. Teleflex Product Code: 200101-01.
| Date | May 1, 2014 (initiated Mar 11, 2014) |
| Status | Terminated |
| Reason | The product did not meet minimum and/or average minimum Teleflex resorption strength requirements. |
| Root cause | Other |
| Action | Teleflex Medical sent an Urgent Medical Device Recall Notification dated March 11, 2014. The letter identified the affected product, problem and actions to be taken. Custmers were instructed to return all affected product to Teleflex Medical per the instructions on the Urgent Recall Notice. Customers were asked to complete the enclosed Recall Acknowledgement Form and fax to 1-866-804-9881, Attn: Customer Service. For questions contact your local sales representative or Customer Service at 1-866-246-6990 |
| Quantity | 7,380 ea (total) |
| Distribution | Worldwide Distribution - US Nationwide in the states of CA, CO, GA, LA, IL, MA, MI, MN, MO, NC, and in the countries of Ireland and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992088 | BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE Genzyme Surgical Product (Genzyme Biosurgery), Sep 3, 1999 |