Synthes Sciatic Nerve Retractor Recall for Potential Fluid Ingress
Synthes (USA) Products LLC is recalling 1,113 Sciatic Nerve Retractors due to a potential for micropores to form, which could allow fluid to enter the hollow handle.
What this means for you
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 the hazard involves a risk of harm (fluid ingress) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Synthes (USA) Products LLC is recalling 1,113 units of the Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long. These instruments are system-specific to the 3.5 mm Low Profile Pelvic System Retractor Set. The recall is classified as Class II by the U.S. Food and Drug Administration.
The reason for the recall is the potential for micropores to form in the instruments, which could allow fluid to enter the hollow handle. The affected products were distributed nationwide and internationally, including Canada. Specific part numbers and lot numbers are listed in the agency's recall record.
Healthcare facilities and distributors should stop using the affected instruments and contact Synthes (USA) Products LLC for further instructions. Consumers who have purchased these items should contact the manufacturer or their healthcare provider for guidance.
The recalled product
- Product
- Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long are system specific instruments to the 3.5 mm Low Profile Pelvic System Retractor Set.
- Manufacturer
- Synthes (USA) Products LLC
- Affected units
- 1,113
Distribution
Distributed nationwide across the United States.
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