Reported Jun 5, 2019 · Terminated
Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30
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 Disc30mm 3mm2ccCatalog Number 600-03-30
- Lot codes and dates
- UDI 10885862093202 Serial Numbers
T31634510T31788559
- UDI 10885862093202 Serial Numbers
- Amount recalled
- 2 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Exactech, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.