Synthes Sciatic Nerve Retractor Recalled for Potential Microspore Formation
Synthes (USA) Products LLC is recalling 196 Sciatic Nerve Retractors due to a potential for microspores to form on the hollow handle, which could allow fluid entry.
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, but the source text describes a potential defect without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Synthes (USA) Products LLC is recalling 196 units of the Retractor f/Sciatic Nerve Long (Part number: 03.100.014; UDI: 10886982070630). The recall is due to a potential for microspores to form on the hollow handle of the device. These pores may increase in size, allowing fluid to enter the hollow handle.
The affected products were distributed in the United States and Canada. The recall includes specific lot numbers: T104993, T108115, T114598, T140566, T140665, T140670, T140671, T140673, T141540, T143687, T144854, T145585, T145590, T145932, T146657, T147929, T148552, T148553, T149727, T149728, T151369, T151488, T152808, T152809, T153884, T155649, and T958061.
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices. Users should contact Synthes (USA) Products LLC for further instructions on how to return or dispose of the recalled items.
The recalled product
- Product
- Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630
- Manufacturer
- Synthes (USA) Products LLC
- Affected units
- 196
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)
- Lot numbers: T104993
- T108115
- T114598
- T140566
- T140665
- T140670
- T140671
- T140673
- T141540
- T143687
- T144854
- T145585
- T145590
- T145932
- T146657
- T147929
- T148552
- T148553
- T149727
- T149728 T151369
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Synthes (USA) Products LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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