BioHorizons Implant Systems Inc One Perimeter Park South BioHorizons 0.050 Hex Driver, Long, REF 300-351, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BioHorizons 0.050 Hex Driver, Long, REF 300-351, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only
Brand
BioHorizons Implant Systems Inc One Perimeter Park South
Lot Codes / Batch Numbers
Lot No. 08060239
Products Sold
Lot No. 08060239
BioHorizons Implant Systems Inc One Perimeter Park South is recalling BioHorizons 0.050 Hex Driver, Long, REF 300-351, BioHorizons Implant Systems, Inc., Birmingham, AL due to Premature Wear; The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature wear.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Premature Wear; The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature wear.
Recommended Action
Per FDA guidance
Letters and replacement drivers were sent to the consignees (both domestic and abroad) on 3/12/2007 explaining the problem and requesting that the consignee discard the instrument and use the replacement. They were delivered via United Parcel Service (UPS) 3rd day package delivery.
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 noticePage updated: Jan 10, 2026