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Recall Observatory FDA recall evidence

Device product

Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head element insertion.

Z-0126-2016

September 21, 2015

Class II

Product summary

Firm
Synthes (USA) Products LLC
Event
Event 72243
Status
Terminated
Classification
Class II
Quantity
793
Official record key
device-enforcement:Z-0126-2016

Official wording

Reason: Certain lots of the Screw Inserter may be etched with incorrect graphics. The orientation of the etched image of the oblique angle on the Screw Inserter may not correspond to the tip of the angle of the instrument.

Code information: Part Number 03.037.025 Lot Numbers 8911887; 8911975; 9166356; 9285766; 9286671; 9319408; 9375245; 9375251; 9388359; 9388360; 9393071; 9393074; 9393075; 9393076; 9409795; 9409796; 9422892; 9422895; 9498455; 9310899; 9310900; 9319407

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Certain lots of the Screw Inserter may be etched with incorrect graphics. The orientation of the etched image of the oblique angle on the Screw Inserter may not correspond to the tip of the angle of the instrument.