FDA Medical Device Recalls (openFDA)
The Anspach Effort, Inc.: Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical power tool.
- Recall number
- Z-2345-2015
- Recalling firm
- The Anspach Effort, Inc.
- Product
- Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical power tool.
- Status
- Terminated
- Initiated
- 2015-07-01
- Posted
- 2015-08-05
- Terminated
- 2016-12-14
- Reason
- Saw head separated from the drive unit or began to come loose.
- Root cause
- Nonconforming Material/Component
- Action
- DePuy Synthes sent an " Urgent Notice Medical Device Recall (Removal) letter dated July 1, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. ACTION REQUIRED: Our records show that your facility has the affected product(s) subject to this removal. The Anspach Effort, on behalf of DePuy Synthes asks that you review your inventory and immediately remove any affected BPLII Battery Oscillator devices from stock. In addition to this letter, your DePuy Synthes Sales Consultant has been provided with new product(s) to immediately replace the affected product(s). If you have any questions regarding this removal, please contact the Complaint Handling Unit Manager at 561-494-3673 or contact your DePuy Synthes Sales Consultant.
- Quantity
- 360 handpieces (Currently there are 9 affected units remaining in the US and 17 units OUS all others were reworked)
- Distribution
- Worldwide Distribution - US Distribution to the states of : AR, LA, OH, and WA., and the countries of : China, France, Italy, Russia, South Africa, Switzerland, and United Kingdom.
- Lot, serial or model codes
- Serial numbers: 100067, 100076, 100371, 100372, 100063, 100065, 100069, 100076, and 100055; Foreign: Item number 530.710 Serial numbers: 100020, 100026, 100039, 100248, 100254, 100257, 100263, 100265, 100269, 100270, 100293, 100296, 100307, 100313, 100315, 100339, and 100340.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HTZ
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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