Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178
FDA device recall Z-0536-2013 · posted 2012-12-17 · Terminated
Recall details
- Recalling firm
- Ebi, Llc
- Reason for recall
- Broken screw insertor hardness was measured and found to be below the acceptable limits.
- Action taken
- Biomet mailed Urgent Medical Device Recall Notice/Fax Back Response Form dated 9/25/2012 to the distributors on 9/29/2012.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HXX
- Quantity affected
- 15 units
- Distribution
- Nationwide Distribution, including the states of MO, TX, and IN.
- Date initiated
- 2012-09-29
- Date posted
- 2012-12-17
- Date terminated
- 2015-12-07
- Location
- Parsippany, NJ
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