Z-1947-2009

ACT3020 Advanced Cutting technology (ACT) Twist Drill 3.0mm(D) X 20mm(L). BIOMET 3i 455 Riverside Drive, Palm...

Name: Z-1947-2009 ACT3020 Advanced Cutting technology (ACT) Twist Drill 3.0mm(D) X 20mm(L). BIOMET 3i 455 Riverside Drive, Palm...
Creator: Biomet 3i, LLC
Published: 2009-06-29
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2009-06-29 / Terminated / root cause: packaging

FDA source

Biomet 3i, LLC began a recall of ACT3020 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... on 2009-06-29. The reason FDA records is "Some of the packages of ACT3020, drills may actually contain an ACT3220 drill". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1947-2009
Status: Terminated
Initiated: 2009-06-29
Posted: 2009-09-01
Terminated: 2010-01-05
Recalling firm: ZimVie US Corp LLC
Product: ACT3020 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.
Product code: DZA Drill, Dental, Intraoral
Reason for recall: Some of the packages of ACT3020, drills may actually contain an ACT3220 drill.
Root cause tag: packaging
FDA root cause: Mixed-up of materials/components
Action: Consignees 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 commerce: 29 units
Distribution: Worldwide Distribution -- Korea, Netherlands, Taiwan, United Kingdom, and USA.
Product codes and lots: Lot # 860172

Product code DZA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)