Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178
This recall has been terminated (originally issued December 17, 2012).
- Company
- Ebi, Llc
- Recall Initiated
- September 29, 2012
- Posted
- December 17, 2012
- Terminated
- December 7, 2015
- Recall Number
- Z-0536-2013
- Quantity
- 15 units
- Firm Location
- Parsippany, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Broken screw insertor hardness was measured and found to be below the acceptable limits.
Distribution
Nationwide Distribution, including the states of MO, TX, and IN.
Lot / Code Info
Lot Numbers 540199, 540199-1
Root Cause
Process control
Action Taken
Biomet mailed Urgent Medical Device Recall Notice/Fax Back Response Form dated 9/25/2012 to the distributors on 9/29/2012.
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