Z-0624-2018 Class II Terminated
FDA device recall Z-0624-2018 was initiated by Aesculap Implant Systems LLC on September 8, 2017 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated April 4, 2019). Affected quantity: 292 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 21, 2018
- Initiation Date
- September 8, 2017
- Termination Date
- April 4, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 292 units
Product Description
JS Series SterilContainer S2 System
Reason for Recall
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.
Distribution Pattern
Nationally
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