Z-2345-2015 Class II Terminated
FDA device recall Z-2345-2015 was initiated by The Anspach Effort, Inc. on Jul 1, 2015 and is designated Class II. Reason for recall: Saw head separated from the drive unit or began to come loose. The recall status is terminated (terminated Dec 14, 2016). Affected quantity: 360 handpieces (Currently there are 9 affected units remaining in the US and 17 units OUS all others were reworked).
Recall Details
- Product Type
- Devices
- Report Date
- Aug 12, 2015
- Initiation Date
- Jul 1, 2015
- Termination Date
- Dec 14, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 360 handpieces (Currently there are 9 affected units remaining in the US and 17 units OUS all others were reworked)
Product Description
Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical power tool.
Reason for Recall
Saw head separated from the drive unit or began to come loose.
Distribution Pattern
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.
Code Information
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2345-2015
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026