Z-2126-2016 Class II Terminated

Recalled by The Anspach Effort, Inc. — Palm Beach Gardens, FL

FDA device recall Z-2126-2016 was initiated by The Anspach Effort, Inc. on Nov 25, 2015 and is designated Class II. Reason for recall: Has the incorrect operating directions on the mode switch ring, i.e. its is labeled "FWD, LOCK, REV" instead of "ON, LOCK, ON". The recall status is terminated (terminated Nov 14, 2018). Affected quantity: 20 hand pieces.

Recall Details

Product Type
Devices
Report Date
Jul 13, 2016
Initiation Date
Nov 25, 2015
Termination Date
Nov 14, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20 hand pieces

Product Description

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

Reason for Recall

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

Distribution Pattern

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

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

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-2126-2016
openFDA file date
Oct 26, 2026
Loaded by RegDataLab
Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.