Synthes Battery Power Line II Oscillator recall
Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical power tool.
Why was Synthes Battery Power Line II Oscillator recalled?
Saw head separated from the drive unit or began to come loose.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical power tool.
- Recalling firm
- The Anspach Effort, Inc.
- 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.
- Recall date
- August 12, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)