FDA Device

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

Hazard

Instrument is excessively flexible making it unusable by the surgeon.

What You Should Do

Remedy

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.

Products

Product is packed in plastic Tyvek packaging and is labeled as sterile as follows: ACUDRIVER FLEXIBLE OSTEOTOME FLAT NARROW REF: 400-40-14
Brand
Exactech, Inc.
UPC
Lot 432978 Serial Numbers 0460912 to 0460954 Lot 433954 Serial Numbers 0471589 to 0482514 Lot 434846 Serial Numbers 0482490-0482514

Units Affected

18