Z-2345-2015Class II

Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical power tool

Name: Z-2345-2015 Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical power tool
Creator: The Anspach Effort, Inc.
Published: 2015-07-01
License: https://open.fda.gov/license/

The Anspach Effort, Inc. / initiated 2015-07-01 / Terminated / root cause: manufacturing process

FDA source

The Anspach Effort, Inc. began a recall of Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical power tool on 2015-07-01. FDA classified it as Class II and gives the reason as "Saw head separated from the drive unit or began to come loose". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2345-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-01
Posted: 2015-08-05
Terminated: 2016-12-14
Recalling firm: The Anspach Effort, Inc.
Product: Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical power tool.
Product code: HTZ Instrument, Cutting, Orthopedic
Reason for recall: Saw head separated from the drive unit or began to come loose.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2345-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2345-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-12	2015-08-05

Product code HTZ

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)