—#171233

Product

CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible

FDA product code: NHA — Abutment, Implant, Dental, Endosseous
Device class: Class 2
Medical specialty: Dental
510(k) numbers: K052648, K102209
Affected lot / code info: Lot Numbers/UDI: 8442784-1/(01)00844868031130(10)8442784-1, 8442469-1/(01)00844868031130(10)8442469-1, 8442689-1/(01)00844868031130(10)8442689-1

Why it was recalled

During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.

Root cause (FDA determination)

Process control

Action the firm took

The firm disseminated the notices by email on 02/26/2019. The letter requested that the dental laboratories quarantine and return any unused product and to further notify the affected clinician referral.

Recalling firm

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

Distribution

Distribution pattern: Nationwide and Puerto Rico, Canada, and Australia

Timeline

Recall initiated: 2019-02-26
Terminated: 2020-06-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171233. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.