—#117652

Product

Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)

FDA product code: DZE — Implant, Endosseous, Root-Form
Device class: Class 2
Medical specialty: Dental
510(k) numbers: K122300
Affected lot / code info: Lot number: 2012111613 Exp 2017/12 Catalog #: BOPS6510

Why it was recalled

A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, is label correctly. This condition, if present and not recognized could potentially result in the dental implant not being able to be placed into the osteotomy or seated to the desired depth if placement is attempted.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

The firm issued "Urgent Medical Device Recall" notification letters to their customers dated May 10, 2013. The notification described the issue and provided recommendations actions regarding affected product. Customers with questions may contact 1 800-342-5454.

Recalling firm

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

Distribution

Distribution pattern: Distribution to the state of Massachusetts, and the foreign countries of Australia, Belgium, Spain, Denmark, France, Luxembourg, Switzerland, Germany, Bonaire, Sweden, and Italy.

Timeline

Recall initiated: 2013-05-10
Posted by FDA: 2013-08-13
Terminated: 2014-08-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #117652. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.