JS Series SterilContainer S2 System

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Aesculap Implant Systems LLC
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

JS Series SterilContainer S2 System

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0624-2018

Related Recalls

Potential for the spring to become loose and fall out of the device, if the spring falls out during a surgical procedure, it may enter the patient's body.

Mar 21, 2023 Surgical Instruments Nationwide View Details →