Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623
Reported: May 16, 2018 Initiated: April 2, 2018 #Z-1758-2018
Product Description
Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623
Reason for Recall
There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. The pores may increase in size, allowing fluid to enter the hollow handle.
Details
- Recalling Firm
- Synthes (USA) Products LLC
- Units Affected
- 235
- Distribution
- US Nationwide and Canada
- Location
- West Chester, PA
Frequently Asked Questions
What product was recalled? ▼
Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623. Recalled by Synthes (USA) Products LLC. Units affected: 235.
Why was this product recalled? ▼
There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. The pores may increase in size, allowing fluid to enter the hollow handle.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 16, 2018. Severity: Moderate. Recall number: Z-1758-2018.
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