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Recall Observatory FDA recall evidence

Device product

Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc.

Z-2126-2016

November 25, 2015

Class II

Product summary

Firm
The Anspach Effort, Inc.
Event
Event 73198
Status
Terminated
Classification
Class II
Quantity
20 hand pieces
Official record key
device-enforcement:Z-2126-2016

Official wording

Reason: Has the incorrect operating directions on the mode switch ring, i.e. its is labeled "FWD, LOCK, REV" instead of "ON, LOCK, ON".

Code information: Part Number 530.710, Serial Numbers 101066, 101067, 101068, 101069, 101070, 101071, 101072, 101073, 101074, 101075, 101076, 101077, 101078, 101079, 1011080, 101081, 101082, 101083, 101084, 101085

Distribution pattern: US Distribution to the state of : VA and Internationally to: Thailand and UK

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Has the incorrect operating directions on the mode switch ring, i.e. its is labeled "FWD, LOCK, REV" instead of "ON, LOCK, ON".