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Recall Observatory FDA recall evidence

Device product

JS Series SterilContainer S2 System

Z-0624-2018

September 08, 2017

Class II

Product summary

Firm
Aesculap Implant Systems LLC
Event
Event 79089
Status
Terminated
Classification
Class II
Quantity
292 units
Official record key
device-enforcement:Z-0624-2018

Official wording

Reason: The JS Series SterilContainer S2 System was released to the market place prior to an authorized FDA 510K clearance. No other Aesculap SterilContainer System products are impacted by this recall.

Code information: JS440 S2 1/1CONT.BOTTON PERFOR.H88MM H202 JS441 S2 1/1 CONT.BOTTOMPERFOR.H1118MM H202 JS442 S2 1/1-CONT.BOTTOM PERFOR.H133MM H202 JS444 S2 1/1 CONT.BOTTOM PEFOR.H185MM H202 JS489 S2 1/1-CONTAINER LID H202 JS740 S2 3/4 CONT.BOTTOM PERFOR.H88MMH202 JS741 S2 3/4 CONT.BOTTOM PERFOR.H118MM H202 JS742 S2 3/4 CONT.BOTTOM PERFOR.H133MM H202 JS789 S2 3/4 CONTAINER LID H202 JS340 S2 1/2 CONT.BOTTOM PERFOR.H88MM H202 JS341 S2 1/2 CONT.BOTTOM PERFOR.H118MM H202 JS342 S2 1/2 CONT.BOTTOM PERFOR.H133MM H202 JS389 S2 1/2 CONTAINER LID H202

Distribution pattern: Nationally

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The JS Series SterilContainer S2 System was released to the market place prior to an authorized FDA 510K clearance. No other Aesculap SterilContainer System products are impacted by this recall.