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Recall Observatory FDA recall evidence

Device product

Exactech Optetrak Logic CC 15mm Tibial Augment Screws

Z-2704-2017

April 07, 2017

Class II

Product summary

Firm
Exactech, Inc.
Event
Event 77514
Status
Terminated
Classification
Class II
Quantity
9 devices
Official record key
device-enforcement:Z-2704-2017

Official wording

Reason: Missing Screw in carton. Nine (9) serial numbers were identified as being inadvertently packaged as one per carton when two per carton are required.

Code information: Catalog No. 02-012-50-9015; Serial #'s 4739530, 4739531, 4739532, 4739533, 4739534, 4739535, 4739536, 4739537, and 4739538.

Distribution pattern: CA and NY.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Missing Screw in carton. Nine (9) serial numbers were identified as being inadvertently packaged as one per carton when two per carton are required.