SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader

• • Ongoing Z-2999-2020 FDA Class II ·initiated 17 Aug 2020 ·on shared 510(k) K163142

  Due to a supplier error where a portion of the raw material was inadvertently mixed. As a result, some needles may be made of commercially pure titanium as opposed to 304 stainless steel which does not meet the specification and could potentially break during use.

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

510(k) Number

K163142 ↗

FDA Product Code

GAT

Models / Variants

SpeedStitch Suture Passer

SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack

SpeedStitch Needle Loader and Unloader

Device Class

Class II

Regulation

21 CFR Part 878.5000

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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