Recall Z-2662-2017— Exactech, Inc.
Class II · Terminated
Class II FDA medical device recall by Exactech, Inc., initiated 2017-05-25, terminated 2019-07-26. FDA's recall record names no specific 510(k) clearance for this event. Product: Logic Fit Tibial Tamp Head. Reason: The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to remove the tamp assembly from the bone, i.e., to include a caution statement about the potential for instrument breakage if the tamp handle/guide is misused by impacting in retro-grade..
- Recalling firm
- Exactech, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-05-25
- Terminated
- 2019-07-26
- Firm location
- Gainesville, FL, United States
Product description
Logic Fit Tibial Tamp Head
Reason for recall
The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to remove the tamp assembly from the bone, i.e., to include a caution statement about the potential for instrument breakage if the tamp handle/guide is misused by impacting in retro-grade.
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