FDA Medical Device Recalls (openFDA)
The Anspach Effort, Inc.: Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc.
- Recall number
- Z-2126-2016
- Recalling firm
- The Anspach Effort, Inc.
- Product
- Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc.
- Status
- Terminated
- Initiated
- 2015-11-25
- Posted
- not on file
- Terminated
- 2018-11-14
- Reason
- 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
- 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
- 20 hand pieces
- Distribution
- US Distribution to the state of : VA and Internationally to: Thailand and UK
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MOQ
- Firm FEI
- 1045834
- Firm city
- Palm Beach Gardens
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28