Synthes Sciatic Nerve Retractor Recalled for Potential Microspore Formation
Synthes (USA) Products LLC is recalling 235 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 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. The hazard involves a potential for fluid entry into a surgical instrument, which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Synthes (USA) Products LLC is recalling 235 units of the Retractor f/Sciatic Nerve (Part number: 03.100.013; UDI: 10886982070623). The recall is classified as Class II by the U.S. Food and Drug Administration.
The recall is issued because there is 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 units were distributed nationwide in the United States and in Canada.
Healthcare facilities and consumers should check their inventory for the specific lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to the manufacturer or an authorized distributor for credit or replacement, in accordance with standard recall procedures.
The recalled product
- Product
- Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 235
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: T104992
- T114599
- T140390
- T140674
- T140675
- T140676
- T140677
- T141539
- T143644
- T144855
- T145296
- T145589
- T145819
- T146660
- T147930
- T148624
- T149725
- T149726
- T151370
- T152806
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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