REF 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 4.5mm***Use with 20mm Screw***STERILE***EXACTECH 2320
FDA device recall Z-2364-2012 · posted 2012-09-11 · Terminated
Recall details
- Recalling firm
- Exactech, Inc.
- Reason for recall
- Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.
- Action taken
- The firm, Exactech, Inc., called the lone customer on January 24, 2012 to discuss the product, problem and actions to be taken. The customer was instructed to return all unused devices and associated packaging.
- Root cause
- Finished device change control
- Status
- Terminated
- Product code
- HTW
- Quantity affected
- 2
- Distribution
- Nationwide distribution: USA state of: Arkansas only
- Date initiated
- 2012-01-24
- Date posted
- 2012-09-11
- Date terminated
- 2012-09-26
- Location
- Gainesville, FL
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