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U.S. Department of Health and Human Services

Class 2 Device Recall ACT3020 Twist Drill

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 Class 2 Device Recall ACT3020 Twist Drillsee related information
Date Initiated by FirmJune 29, 2009
Date PostedSeptember 01, 2009
Recall Status1 Terminated 3 on January 05, 2010
Recall NumberZ-1947-2009
Recall Event ID 52604
Product Classification Intraoral Dental Drill - Product Code DZA
ProductACT3020 Advanced Cutting technology (ACT) Twist Drill 3.0mm(D) X 20mm(L). BIOMET 3i 455 Riverside Drive, Palm Beach Gardens, FL 33410 USA. Made in Switzerland. Twist drill for preparation of osteotomy during dental implant surgical drilling procedure.
Code Information Lot # 860172
Recalling Firm/
Manufacturer		 Biomet 3i, LLC
4555 Riverside Dr
Palm Beach Gardens FL 33410-4200
For Additional Information ContactKelly Taylor
561-776-6700
Manufacturer Reason
for Recall		Some of the packages of ACT3020, drills may actually contain an ACT3220 drill.
FDA Determined
Cause 2		Mixed-up of materials/components
ActionConsignees were notified of recall by telephone and by faxed an Urgent: Medical Device Recall letter, dated June 30, 2009. The letter stated the problem. The letter also asked customers to check their surgical kits and confirm the drill is placed in the correct space within the kit. Customers are to verify that the shank of the drill is marked as ACT3020 on one side and as 3.0 x 20mm on the opposite side. The letter also stated the clinical implications. Customers are to respond with the attached response fax and then return the drills to BIOMET 3i. Once the returned product is received, replacement drills will be sent to the customers. Questions or concerns should be directed to Kelly Taylor at 561-776-6906.
Quantity in Commerce29 units
DistributionWorldwide Distribution -- Korea, Netherlands, Taiwan, United Kingdom, and USA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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