Recall Z-0536-2013— Ebi, Llc
Class II · Terminated
Class II FDA medical device recall by Ebi, Llc, initiated 2012-09-29, terminated 2015-12-07. FDA's recall record names no specific 510(k) clearance for this event. Product: Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178. Reason: Broken screw insertor hardness was measured and found to be below the acceptable limits..
- Recalling firm
- Ebi, Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-09-29
- Terminated
- 2015-12-07
- Firm location
- Parsippany, NJ, United States
Product description
Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178
Reason for recall
Broken screw insertor hardness was measured and found to be below the acceptable limits.
Data sourced from openFDA. This site is unofficial and independent of the FDA.