Howmedica Osteonics Corp. 2024-05-01 Health serious FDA
Health · FDA · Recall #FDA-Z-1628-2024
TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high… Recall
Issued May 1, 2024 · Howmedica Osteonics Corp.
In May 2024, Howmedica Osteonics Corp. recalled the TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
What you should do
- 1 Stop using TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Howmedica Osteonics Corp. 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
- Howmedica Osteonics Corp.
- Category
- Health
- Recall date
- May 1, 2024
- Units affected
- Not reported
- Sold at
- Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
- Recall number
- FDA-Z-1628-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Howmedica Osteonics Corp. has 12 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.