—#108182

Product

Certain Low-Profile, Angled Abutment, Model Number ILPAC3217. Product is labeled in part: "***Biomet 3i***4555 Riverside Drive , Palm Beach Gardens, FL 33410 USA***REF ILPAC3217***LOT 2011091179***Certain Low Profile 17 Abutment***3.4mm(D) X 2mm(H)***Abutment:; Pillar; Abutment; Abutment; Pilastro; Pillar***CE dose***Use by 2016-09***Sterile using Radiation***RX Only***Do not reuse***Consult accompanying documents***Do not re-sterilize***Do not use if package is damaged***ILPAC3217***2011091179***"P-LBLNY3P***Rev. D***". Intended to provide a means to attach crown restorations or implant frameworks to implants.

FDA product code: NHA — Abutment, Implant, Dental, Endosseous
Device class: Class 2
Medical specialty: Dental
510(k) numbers: K092341
Affected lot / code info: Lot Numbers: 2011060659, 2011070773, 2011070988, 2011071332, 2011071575, 2011080241, 2011080697, and 2011091179.

Why it was recalled

Biomet 3i initiated a recall for a small percentage of the 33mm (ILPAC3217) abutment packages that may contain the 5mm (ILPAC5217) abutment.

Root cause (FDA determination)

Material/Component Contamination

Action the firm took

Biomet 3i , LLC sent Urgent: Medical Device Recall notices on 1/10/2012 to each customer in via e-mail, facsimile, telephone or postal mail. The letters identified the affected product and the reason for the recall. Each customer was instructed to check their respective inventory for the affected product and return any unused product to Biomet 3i at the address provided. Biomet 3i will issue replacement product at no charge. Questions or concerns should be directed to 1-800-342-5454.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- Canada, Chile, Columbia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Singapore, South Africa, Spain, Sweden, Switzerland, UK, US, and Vietnam.

Timeline

Recall initiated: 2012-01-10
Posted by FDA: 2012-04-25
Terminated: 2012-04-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #108182. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.