Z-0105-04

Product is packed in plastic Tyvek packaging and is labeled as sterile as follows: ACUDRIVER FLEXIBLE...

Name: Z-0105-04 Product is packed in plastic Tyvek packaging and is labeled as sterile as follows: ACUDRIVER FLEXIBLE...
Creator: Exactech, Inc.
Published: 2003-06-17
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2003-06-17 / Terminated

FDA source

Exactech, Inc. began a recall of Product is packed in plastic Tyvek packaging and is labeled as sterile as follows: ACUDRIVER FLEXIBLE OSTEOTOME FLAT NARROW REF: 400-40-14 on 2003-06-17. The reason FDA records is "Instrument is excessively flexible making it unusable by the surgeon". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0105-04
Status: Terminated
Initiated: 2003-06-17
Posted: 2003-11-11
Terminated: 2003-11-10
Recalling firm: Exactech, Inc.
Product: Product is packed in plastic Tyvek packaging and is labeled as sterile as follows: ACUDRIVER FLEXIBLE OSTEOTOME FLAT NARROW REF: 400-40-14
Product code: HTZ Instrument, Cutting, Orthopedic
Reason for recall: Instrument is excessively flexible making it unusable by the surgeon.
FDA root cause: Other
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.
Quantity in commerce: 18
Distribution: Product was distributed to five distributors in the following states: LA, ME, NV, and GA.
Product codes and lots: Lot 432978 Serial Numbers 0460912 to 0460954 Lot 433954 Serial Numbers 0471589 to 0482514 Lot 434846 Serial Numbers 0482490-0482514

Product code HTZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)