Reported Jun 5, 2019 · Terminated
Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90
Exactech, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Exactech, Inc. · 2320 NW 66th Ct · Gainesville, FL · 32653-1630
Is this the product you have?
Opteform Allograft Disc90mm x 5mm22ccCatalog Number 600-03-90
- Lot codes and dates
- UDI 10885862094100 Serial Numbers
T31977961T31977962T31977968
- UDI 10885862094100 Serial Numbers
- Amount recalled
- 3 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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