Exactech Opteform Discs: Cold Storage Failure Risk
Exactech recalls Opteform Allograft Discs (30mm, 45mm, 90mm) due to potential cold storage equipment failure causing higher temperatures than specified. Affected units have specific catalog and serial numbers.
Lower-risk recall
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.
Contact the company
What happened, in plain English
Exactech is recalling Opteform Allograft Discs that may have been exposed to higher temperatures than intended due to cold storage equipment failure. This could affect the disc's safety and effectiveness for medical use. Read more at govinfonow.com/recall/68012-exactech-opteform-discs-cold-storage-failure-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/68012-exactech-opteform-discs-cold-storage-failure-risk · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1688-2019
Cite this page
“Exactech Opteform Discs: Cold Storage Failure Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/68012-exactech-opteform-discs-cold-storage-failure-risk. Based on FDA recall #Z-1688-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1688-2019%22&limit=1).
Why it’s dangerous
The discs were potentially exposed to higher temperatures than documented in the instructions because of a cold storage equipment failure. This could compromise the disc's integrity and safety for medical use.
Who’s affected
Patients using these discs for medical procedures are affected. Healthcare providers who received the discs from the manufacturer are most at risk.
How to tell if you have this one
Check for catalog number 600-03-30 and serial numbers T31634510 or T31788559. The discs are 30mm, 3mm, 2cc in size.
- Brand
Exactech- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
OK, VA, FL
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1688-2019 | Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30; UDI 10885862093202 Serial Numbers: T31634510, T31788559 | 2 units |
| Z-1689-2019 | Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45; UDI 10885862093219 Serial Numbers: T32309666, T32309672 | 2 units |
| Z-1690-2019 | Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90; UDI 10885862094100 Serial Numbers: T31977961, T31977962, T31977968 | 3 units |
What to do — step by step
Check Product Details
Verify the catalog number and serial numbers to confirm if your disc is affected.
Where it went and when
Where it was distributed
Distributed in 3 states.
FDA distribution: “OK, VA, FL” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, Oklahoma, Virginia.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Are these discs safe to use?
The recall indicates potential temperature exposure, but the discs may still be safe for use if properly stored. Exactech has not specified a remedy.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1688-2019 (April 26, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1688-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.