Monodek Synthetic Absorbable Surgical Suture

• • Terminated Z-1534-2014 FDA Class II ·initiated 11 Mar 2014

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

• • Terminated Z-1509-2014 FDA Class II ·initiated 11 Mar 2014

  Product does not meet minimum knot tensile strength requirements.

• • Terminated Z-1016-2007 FDA Unclassified (pre-2012) ·initiated 6 Jun 2007 ·on shared 510(k) K030212

  The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K030212 ↗

FDA Product Code

NEW

Device Class

Class II

Regulation

21 CFR Part 878.4840

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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