Exactech, Inc. Product is packed in plastic Tyvek packaging and is labeled as sterile as follows: ACUDRIVER FLEXIBLE OSTEOTOME FLAT NARROW REF: 400-40-14 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lot 432978 Serial Numbers 0460912 to 0460954 Lot 433954 Serial Numbers 0471589 to 0482514 Lot 434846 Serial Numbers 0482490-0482514
Exactech, Inc. is recalling Product is packed in plastic Tyvek packaging and is labeled as sterile as follows: ACUDRIVER FLEXIBL due to Instrument is excessively flexible making it unusable by the surgeon.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Instrument is excessively flexible making it unusable by the surgeon.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
GA, IN, LA, ME, NV
Page updated: Jan 10, 2026