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Recall Observatory FDA recall evidence

Device product

MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636

Z-2242-2016

June 21, 2016

Class II

Product summary

Firm
Encore Medical, Lp
Event
Event 74484
Status
Terminated
Classification
Class II
Quantity
14 (7 sets)
Official record key
device-enforcement:Z-2242-2016

Official wording

Reason: Reported failure of the instrument. The retaining ring component of a neck trial became disassembled from the body of the neck.

Code information: Lot: 313R1000, 313R1900, 313R1901, 314R1000, 314R1900, 314R1901

Distribution pattern: CO, ID, TX

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Reported failure of the instrument. The retaining ring component of a neck trial became disassembled from the body of the neck.