Synthes Flex Arm Recalled for Potential Connection Failure
Synthes, Inc. is recalling 84 Flex Arm units because the quick connect feature may fail to connect to mating parts.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Synthes, Inc. is recalling 84 units of the Synthes Flex Arm, a component of the Synthes Minimally Invasive Support System used for table mounting in minimally invasive spine surgery. The recall is due to a defect where the quick connect feature of the instruments may be unable to connect to the male features of Flex Arm Adaptors, Insight Retractors, or other mating parts.
The affected units were distributed worldwide, including the United States, Canada, Switzerland, and Japan. The recall covers specific lot numbers: 9833185, 9866629, 9888308, 9914323, 9940637, 9982802, H044106, H072780, H144265, H212060, H260544, H260547, H305886, H347867, H430221, and H430230.
Healthcare providers and facilities should stop using the affected Flex Arm units and contact Synthes, Inc. for further instructions on the recall.
The recalled product
- Product
- Flex Arm Product Usage: The Synthes Flex Arm is a component of the Synthes Minimally Invasive Support System, which provides secure table mounting for minimally invasive spine surgery. The Flex Arm is designed to hold Synthes Minimally Invasive Retractors, which are…
- Manufacturer
- Synthes, Inc.
- Hazard
- Affected units
- 84
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 (16)
- Lot numbers 9833185
- 9866629
- 9888308
- 9914323
- 9940637
- 9982802
- H044106
- H072780
- H144265
- H212060
- H260544
- H260547
- H305886
- H347867
- H430221
- H430230
Distribution
Distributed nationwide across the United States.
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