FDA recall Z-2704-2017

Product

Exactech Optetrak Logic CC 15mm Tibial Augment Screws

Reason for recall

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

Distribution

CA and NY.

Key facts

Status

Terminated

Initiation date

2017-04-07

Report date

2017-07-19

Termination date

2020-08-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gainesville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2704-2017