Recall Z-1758-2018— Synthes (USA) Products LLC
Class II · Terminated
Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2018-04-02, terminated 2019-10-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623. Reason: 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..
- Recalling firm
- Synthes (USA) Products LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-04-02
- Terminated
- 2019-10-16
- Firm location
- West Chester, PA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.