Z-2126-2016Class II

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

Name: Z-2126-2016 Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc
Creator: The Anspach Effort, Inc.
Published: 2015-11-25
License: https://open.fda.gov/license/

The Anspach Effort, Inc. / initiated 2015-11-25 / Terminated / root cause: labeling and UDI

FDA source

The Anspach Effort, Inc. began a recall of Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc on 2015-11-25. FDA classified it as Class II and gives the reason as "Has the incorrect operating directions on the mode switch ring, i.e. its is labeled "FWD, LOCK, REV" instead of "ON, LOCK, ON"". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2126-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-25
Posted: 2016-07-05
Terminated: 2018-11-14
Recalling firm: The Anspach Effort, Inc.
Product: Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc.
Product code: MOQ Battery, Replacement, Rechargeable
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".
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: DePuy Synthes sent an Urgent Notice Recall Notification dated November 24, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They were instructed to review their inventory and immediately remove any affected devices, complete the verification section of the letter and return it to the Anspach Effort Inc., and return any affected product to their DePuy Synthes Sales Consultant. Any questions regarding this recall / removal contact the Complain Handling Unit Manager at (561) 494-3673 or their DePuy Synthes Sales Consultant. For further questions regarding this, please call (561) 627-1080.
Quantity in commerce: 20 hand pieces
Distribution: US Distribution to the state of : VA and Internationally to: Thailand and UK
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2126-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2126-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-13	2016-07-05

Product code MOQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)