Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Retr
FDA device recall Z-2418-2015 · posted 2015-08-19 · Terminated
Recall details
- Recalling firm
- Synthes (USA) Products LLC
- Reason for recall
- Potential for micropores to form, allowing fluid to enter the hollow handle.
- Action taken
- Urgent recall letters, dated July 29,2015, were sent to end users and sales consultants to inform them of the issue, potential risks, and to provide instructions for returning affected devices and the response form.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GAD
- Quantity affected
- 1113
- Distribution
- Nationwide and internationally, including Canada
- Date initiated
- 2015-07-29
- Date posted
- 2015-08-19
- Date terminated
- 2016-05-19
- Location
- West Chester, PA
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