Z-1690-2019Class II

Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90

Name: Z-1690-2019 Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90
Creator: Exactech, Inc.
Published: 2019-04-26
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2019-04-26 / Terminated / root cause: manufacturing process

FDA source

Exactech, Inc. began a recall of Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90 on 2019-04-26. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1690-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-26
Posted: 2019-05-29
Terminated: 2021-04-22
Recalling firm: Exactech, Inc.
Product: Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90
Product code: MQV Filler, Bone Void, Calcium Compound
Reason for 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.
Root cause tag: manufacturing process
FDA root cause: Environmental control
Action: The firm initiated the recall on 04/26/2019 by electronic mail. The notice requested the consignee cease distribution of the product, notify their customers (the user), quarantine all units subject to recall in inventory, and if any units were implanted to follow-up on the patient's condition 30 days after surgery.
Quantity in commerce: 3 units
Distribution: OK, VA, FL
Product codes and lots: UDI 10885862094100 Serial Numbers: T31977961, T31977962, T31977968

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1690-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1688-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-05	2019-05-29
Z-1689-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-05	2019-05-29
Z-1690-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-05	2019-05-29

Product code MQV

K043421Class IIOpteform, Osteofil, Rti Allograft Paste Ic, Rti Allograft Strip IcRegeneration Technologies, Inc. / cleared 2005-02-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)