Product is packed in plastic Tyvek packaging and is labeled as sterile as follows: ACUDRIVER FLEXIBLE OSTEOTOME FLAT NAR
FDA device recall Z-0105-04 · posted 2003-11-11 · Terminated
Recall details
- Recalling firm
- Exactech, Inc.
- Reason for recall
- Instrument is excessively flexible making it unusable by the surgeon.
- Action taken
- The firm mailed a Recall Notification Letter to each account on June 17, 2003 asking them to cease distribution, return recalled product to them and to subrecall to any accounts they may have distributed to.
- Root cause
- Other
- Status
- Terminated
- Product code
- HTZ
- Quantity affected
- 18
- Distribution
- Product was distributed to five distributors in the following states: LA, ME, NV, and GA.
- Date initiated
- 2003-06-17
- Date posted
- 2003-11-11
- Date terminated
- 2003-11-10
- Location
- Gainesville, FL
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