—#83447

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.

FDA product code: DZA — Drill, Dental, Intraoral
Device class: Class 1
Medical specialty: Dental
Affected lot / code info: Lot # 860172

Why it was recalled

Some of the packages of ACT3020, drills may actually contain an ACT3220 drill.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

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.

Recalling firm

Firm: Biomet 3i, LLC
Address: 4555 Riverside Dr, Palm Beach Gardens, Florida 33410-4200

Distribution

Distribution pattern: Worldwide Distribution -- Korea, Netherlands, Taiwan, United Kingdom, and USA.

Timeline

Recall initiated: 2009-06-29
Posted by FDA: 2009-09-01
Terminated: 2010-01-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #83447. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.