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Terminated

Product is packed in plastic Tyvek packaging and is labeled as sterile as follows: ACUDRIVER FLEXIBLE OSTEOTOME FLAT NARROW REF: 400-40-14

FDA Recall Z-0105-04 · Posted 2003-11-11

Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeHTZ
Date Initiated2003-06-17
Date Terminated2003-11-10
Product Quantity18

Reason for Recall

Instrument is excessively flexible making it unusable by the surgeon.

Firm Action

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

Distribution Pattern

Product was distributed to five distributors in the following states: LA, ME, NV, and GA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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