Anspach Effort Recalls Synthes Oscillator Orthopedic Surgical Power Tools
The Anspach Effort, Inc. is recalling Synthes Battery Power Line II Oscillator Model 530.710 units because the saw head may separate from the drive unit or come loose.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a mechanical defect in a surgical device that poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
The Anspach Effort, Inc. is recalling the Synthes Battery Power Line II Oscillator Model 530.710, an orthopedic surgical power tool. The recall involves 360 handpieces, of which 9 affected units remain in the United States and 17 units are located outside the US; all other units have been reworked.
The recall is being conducted because the saw head may separate from the drive unit or begin to come loose. The affected products were distributed worldwide, including in the US states of Arkansas, Louisiana, Ohio, and Washington, and in the countries of China, France, Italy, Russia, South Africa, Switzerland, and the United Kingdom.
Specific serial numbers for the affected US units include 100067, 100076, 100371, 100372, 100063, 100065, 100069, and 100055. Foreign units with item number 530.710 and serial numbers 100020, 100026, 100039, 100248, 100254, 100257, 100263, 100265, 100269, 100270, 100293, 100296, 100307, 100313, 100315, 100339, and 100340 are also affected. Users should stop using the affected devices and contact the recalling firm for instructions.
The recalled product
- Product
- Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical power tool.
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial numbers: 100067
- 100076
- 100371
- 100372
- 100063
- 100065
- 100069
- and 100055
- Foreign: Item number 530.710 Serial numbers: 100020
- 100026
- 100039
- 100248
- 100254
- 100257
- 100263
- 100265
- 100269
- 100270
- 100293
- 100296
Distribution
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