CLASS II Device recall · Reported 16 May 2018 · FDA Enforcement Report
Retractor f/Sciatic Nerve Long recalled by Synthes (USA) Products
Synthes (USA) Products is recalling Retractor f/Sciatic Nerve Long, distributed nationwide in the US. The recall was initiated on 2 Apr 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1759-2018
- FDA event ID
- 79850
- Recalling firm
- Synthes (USA) Products, West Chester, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Apr 2018
- FDA classified
- 9 May 2018
- Reported
- 16 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 2 Apr 2018 | Recall initiated by company | |
| 9 May 2018 | Classified by FDA | +37 days |
| 16 May 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630
Where it was distributed
US Nationwide and Canada
Questions about this recall
Is Retractor f/Sciatic Nerve Long recalled?
Yes. Synthes (USA) Products recalled Retractor f/Sciatic Nerve Long on 2 Apr 2018. The recall is Class II and its status is Terminated. Recall number Z-1759-2018.
Why was it 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 lots are affected?
Lot numbers: T104993, T108115, T114598, T140566, T140665, T140670, T140671, T140673, T141540, T143687, T144854, T145585, T145590, T145932, T146657, T147929, T148552, T148553, T149727, T149728 T151369, T151488, T152808, T152809, T153884, T155649, T958061
Where was it sold?
US Nationwide and Canada
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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