Recall Z-1560-2014— Teleflex Medical

Name: FDA recall Z-1560-2014
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 2017-08-14. It names one FDA 510(k) clearance: K930738. 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.. Reason: Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use..

Recalling firm: Teleflex Medical
Classification: Class II
Status: Terminated
Initiated: 2014-03-11
Terminated: 2017-08-14
Firm location: Durham, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K930738 — SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETCDeknatel, Inc.·cleared 1994-07-26

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

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.

Reason for recall

Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.

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