Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-2345-2015

July 01, 2015

Class II

Product summary

Firm
The Anspach Effort, Inc.
Event
Event 71659
Status
Terminated
Classification
Class II
Quantity
360 handpieces (Currently there are 9 affected units remaining in the US and 17 units OUS all others were reworked)
Official record key
device-enforcement:Z-2345-2015

Official wording

Reason: Saw head separated from the drive unit or began to come loose.

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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Saw head separated from the drive unit or began to come loose.