Howmedica Osteonics Corp. 2024-09-04 Health serious FDA
Health · FDA · Recall #FDA-Z-2732-2024
Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient… Recall
Issued September 4, 2024 · Howmedica Osteonics Corp.
In September 2024, Howmedica Osteonics Corp. recalled the Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
What you should do
- 1 Stop using Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient… 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
- September 4, 2024
- Units affected
- Not reported
- Sold at
- International distribution to the country of Australia.
- Recall number
- FDA-Z-2732-2024
- 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.