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Recall Observatory FDA recall evidence

Device product

Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45

Z-1689-2019

April 26, 2019

Class II

Product summary

Firm
Exactech, Inc.
Event
Event 82759
Status
Terminated
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-1689-2019

Official wording

Reason: 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.

Code information: UDI 10885862093219 Serial Numbers: T32309666, T32309672

Distribution pattern: OK, VA, FL

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.