Blackstone Sfs Parallel Rod Connectors

• • Terminated Z-0896-2013 FDA Class II ·initiated 1 Feb 2013 ·on shared 510(k) K080407

  There is a possibility that the Set Screw (p/n 90-2923) sub-component of the Parallel Rod Connector Assembly (p/n 52-6800) & Axial Rod Connector (p/n 52-6700) may crack during final tightening. Orthofix Inc received six (6) customer complaints related to set screw cracking between November 15, 2010 and December 2012.

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

510(k) Number

K080407 ↗

FDA Product Code

MNI

Device Class

Class II

Regulation

21 CFR Part 888.3070

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Blackstone Medical, Inc. →