Aesculap Implant Systems LLC 2022-07-27 Health serious FDA
Health · FDA · Recall #FDA-Z-1444-2022
AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code… Recall
Issued July 27, 2022 · Aesculap Implant Systems LLC
In July 2022, Aesculap Implant Systems LLC recalled the AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
What you should do
- 1 Stop using AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Aesculap Implant Systems LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Aesculap Implant Systems LLC
- Category
- Health
- Recall date
- July 27, 2022
- Units affected
- Not reported
- Sold at
- United States Nationwide distribution in the states of CA, CO, IL, IN, MI, NC, NV, OH, PA, SC, TX & WY.
- Recall number
- FDA-Z-1444-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Aesculap Implant Systems LLC has 4 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.