Connector System

• 2 recalls, same reason

  • Terminated Z-1363-2018 FDA Class II ·initiated 23 Feb 2018
  • Terminated Z-1364-2018 FDA Class II ·initiated 23 Feb 2018

  Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: 79-2003) with affected Lot Numbers 002, 003 and 004. Through the company's manufacturing controls, size discrepancies were noted with the drive feature for both the large and small sets screws. As a result, it is possible that (1) the set screw drive feature will not accept the Set Screw Driver (PN: 79-1006) or (2) the driver may get wedged in the corners of the drive feature (false bottom) which may lead to a stripped set screw.

1. 18 Aug 2017 Cleared FDA 510(k) K172194
2. 23 Feb 2018 Recall initiated FDA recalls Z-1363-2018
3. 23 Feb 2018 Recall initiated FDA recalls Z-1364-2018

510(k) Number

K172194 ↗

FDA product code

NKG

Device class

Class II

Regulation

21 CFR Part 888.3075

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

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