FDAFDA · Food and drugs·Recall number Z-1242-2024
Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S
Published March 13, 2024 · Recall initiated: January 24, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Products not sterilized, sterility cannot be confirmed
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Synthes (USA) Products LLC
- Distributor
- Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa.
- Lot
- UDI: 07611819318489 Lot Number: 427P153
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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