Recall Z-1535-2014— Teleflex Medical

Name: FDA recall Z-1535-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-11

Class II · Terminated

Class II FDA medical device recall by Teleflex Medical, initiated 2014-03-11, terminated 2016-03-29. It names one FDA 510(k) clearance: K992088. Product: 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.. Reason: The product did not meet minimum and/or average minimum Teleflex resorption strength requirements..

Recalling firm: Teleflex Medical
Classification: Class II
Status: Terminated
Initiated: 2014-03-11
Terminated: 2016-03-29
Firm location: Research Triangle Park, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K992088 — BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTUREGenzyme Surgical Product (Genzyme Biosurgery)·cleared 1999-09-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

The product did not meet minimum and/or average minimum Teleflex resorption strength requirements.

Data sourced from openFDA. This site is unofficial and independent of the FDA.