Synthes (USA) Products LLC 2022-05-18 Health serious FDA
Health · FDA · Recall #FDA-Z-1072-2022
Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement.… Recall
Issued May 18, 2022 · Synthes (USA) Products LLC
In May 2022, Synthes (USA) Products LLC recalled the Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement.…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis.
What you should do
- 1 Stop using Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement.… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Synthes (USA) Products 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
- Synthes (USA) Products LLC
- Category
- Health
- Recall date
- May 18, 2022
- Units affected
- Not reported
- Sold at
- US Nationwide distribution.
- Recall number
- FDA-Z-1072-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Synthes (USA) Products LLC has 5 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.