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

FDA device recall Z-1947-2009 · posted 2009-09-01 · Terminated

Recall details

Recalling firm

Biomet 3i, LLC

Reason for recall

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

Action taken

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.

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

DZA

Quantity affected

29 units

Distribution

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

Date initiated

2009-06-29

Date posted

2009-09-01

Date terminated

2010-01-05

Location

Palm Beach Gardens, FL