Synthes recalls sciatic nerve retractors with part number 03.100.013 due to potential microspores forming in the handle that could allow fluid to enter. Affected units include specific lot numbers.
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.
Synthes is recalling sciatic nerve retractors with part number 03.100.013 because microspores may form in the hollow handle. This could let fluid enter the handle, potentially causing complications during medical procedures.
Microspores can form inside the hollow handle of the retractor. If these pores grow larger, fluid could enter the handle, which might lead to complications during surgery.
Medical professionals using the sciatic nerve retractor for surgical procedures are most at risk. Patients undergoing surgery with this device may be affected if the retractor is used.
Check for part number 03.100.013 on the retractor. Affected units have specific lot numbers listed in the recall notice.
Look for part number 03.100.013 and the listed lot numbers on the retractor.
Microspores may form in the hollow handle, which could grow larger and allow fluid to enter the handle.
Check for part number 03.100.013 and lot numbers T104992 through T152807 as listed in the recall.
The recall does not specify a remedy, so contact Synthes for further instructions.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-1758-2018 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-1758-2018 from Synthes. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
