—#83494

Product

3i Custom # 5753, OSCM2913, 2.9MMX 3.4MM X 13MM, OSSEOTITE CUSTOM, MICROMINI IMPLANT, LOT # 470258, Sterile. Implant Innovations, Inc. 4555 Riverside Drive, Palm Beach Gardens, FL 33410. Custom temporary cover screws are for use in maintaining the soft tissue during the healing process of a dental restoration.

FDA product code: NDA — Helmet, Cranial, For Protective Use
Device class: Class 1
Medical specialty: Physical Medicine
510(k) numbers: K072642
Affected lot / code info: Lot # 51298

Why it was recalled

Healing Abutment was not made within required manufacturing specification. The product did not have the relief behind the thread, which does not allow proper seating.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Each of the US customers was contacted by phone. Following the phone contacts, Biomet 3i performed a follow- up of each call with a faxed letter. Each customer was instructed to check their respective inventory for the affected product and corresponding lot number. They were then requested to fax back a response form to Biomet 3i Regulatory Services to provide feedback concerning their inventory. They were also instructed to return the affected product to Biomet 3i. Contact Biomet 3i, LLC at 1.561.776.6706, if there are any questions.

Recalling firm

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

Distribution

Distribution pattern: USA and Italy

Timeline

Recall initiated: 2006-12-11
Posted by FDA: 2009-09-22
Terminated: 2009-10-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #83494. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.