Recalls / —

—#179341

Product

CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA356

FDA product code

NHA — Abutment, Implant, Dental, Endosseous

Device class

Class 2

Medical specialty

Dental

510(k) numbers

K072642

Affected lot / code info

Lot Numbers: 1228605

Why it was recalled

Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment

Root cause (FDA determination)

Process control

Action the firm took

Zimmer Biomet issued letter to Distributors, Clinicians via FedX on 1/10/20 stating reason for recall, health risk and action take: Step 1: Quarantine any unused affected products in your inventory for return to Zimmer Biomet Dental. Step 2: Identify any patients currently in your care who have received an affected Certain Encode Healing Abutment with the lot numbers in Table 1. a)If the lot number of the Certain BellaTek Encode Healing Abutment is known: a.If the patient has not yet undergone scanning/impressioning, the affected Certain BellaTek Encode Healing Abutment should be replaced with a new Certain BellaTek Encode Healing Abutment prior to scanning/impressioning. Please contact Zimmer Biomet Dental at the number provided in Step G below for an immediate replacement Certain BellaTek Encode Healing Abutment. b.If the case has already been started and the scan/impression has been sent to a lab, please ask the lab to call BellaTek Customer Service team at the number referenced in Step G below for instructions on how to remediate the case. The lab will not be charged twice for the BellaTek abutment. b)If the lot number of the Certain BellaTek Encode Healing Abutment is unknown, inspect for the product condition using Attachment 2. a.If the referenced product condition is present, please follow the instructions in Step 2a above. The affected healing abutment must be returned to Zimmer Biomet Dental per the below instructions. b.If the referenced condition is not present, reinsert the original healing abutment and release the patient. Complete certificate of Acknowledgement and email to CorporateQuality.PostMarket@zimmerbiomet.com. Questions or concerns call the BellaTek Customer Service team at 1-888-800-8045 between 8:00 am and 5:00pm EST, Monday through Friday.

Recalling firm

Firm

Biomet 3i, LLC

Address

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

Distribution

Distribution pattern

Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK

Timeline

Recall initiated

2020-01-10

Terminated

2021-08-02

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #179341. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.