FDAFDA · Food and drugs·Recall number Z-1688-2019
Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30
Published June 5, 2019 · Recall initiated: April 26, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Exactech, Inc.
- Distributor
- OK, VA, FL
- Lot
- UDI 10885862093202 Serial Numbers: T31634510, T31788559
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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