—#28511

Product

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

FDA product code: HTZ — Instrument, Cutting, Orthopedic
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot 432978 Serial Numbers 0460912 to 0460954 Lot 433954 Serial Numbers 0471589 to 0482514 Lot 434846 Serial Numbers 0482490-0482514

Why it was recalled

Instrument is excessively flexible making it unusable by the surgeon.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Exactech, Inc.
Address: 2320 N.W. 66th Court, Gainesville, Florida 32653

Distribution

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

Timeline

Recall initiated: 2003-06-17
Posted by FDA: 2003-11-11
Terminated: 2003-11-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #28511. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.