Recalls / —

—#148709

Product

3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.

FDA product code

DZE — Implant, Endosseous, Root-Form

Device class

Class 2

Medical specialty

Dental

510(k) numbers

K063341

Affected lot / code info

Model No: IOSS411; Lot No: 2016031461; UDI: (01)00844868007098(17)210401(10)2016031461.

Why it was recalled

Product was incorrectly packaged.

Root cause (FDA determination)

Packaging process control

Action the firm took

An Urgent Medical Device Removal Notice is being sent to Customers August 12, 2016, notifying them of the packaging of OSSEOTITE Certain Implant (4x11.5mm) in T3 Implant boxes. This recall is specific to Lot No. 2016031461. The material shipped within the box was described as being correct ,but only the box it was shipped in was incorrect. Customers were notified that there are no immediate or long term health consequences. In the notification letter, customers are instructed to complete the Certificate of Acknowledgement, and to return it via email (postmarket@zimmerbiomet.com) if no product is on hand or to return the certificate with product by shipping materials to: Biomet 3i - Post-Market Returns. Replacement product will be sent to customers upon return. Customers were also advised to keep a copy of their Certificate of Acknowledgement. Further questions should be directed to 1-800 443-8166 between the hours of 8:00 AM and 6:00 PM, Monday thru Friday. For further questions, please call 1-800 342-5454.

Recalling firm

Firm

Biomet 3i, LLC

Address

4555 Riverside Dr, Palm Beach Gardens, Florida 33410-4200

Distribution

Distribution pattern

US Distributions to the states of : CA and FL., and Worldwide to : Colombia, France, Germany, Italy, and Spain.

Timeline

Recall initiated

2016-08-08

Terminated

2019-08-06

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #148709. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.