Bioanchor with Disposable Driver, Preloaded with One #2 Herculine Suture

• • Terminated Z-1548-05 FDA Unclassified (pre-2012) ·initiated 22 Feb 2005 ·on shared 510(k) K042778

  Linvatec has determined there is a possibility the pouch Tyvek header to foil longitudinal seal was not properly sealed by Bemis Flexible Packaging, in all pouches, prior to sterilization by Linvatec. Therefore there is a potential for compromised sterility of the devices.

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

510(k) Number

K042778 ↗

FDA Product Code

HWC

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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