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Terminated

BIOMET 3i, EP Healing Abutment, REF/Item Number: THA53, 4.1mm(D) X 5mm(P) X 3mm(H), Sterile, BIOMET 3i, Palm Beach, FL

FDA Recall Z-1366-2008 · Posted 2008-03-29

Recalling FirmBiomet 3i, Inc.
Recall StatusTerminated
Product CodeNHA
Date Initiated2008-02-14
Date Terminated2008-07-10
Product Quantity254

Reason for Recall

Mis-labeling: Labeled THA53 device packaging may contain ITHA53 devices (The ITHA53 is designed to be used with an internally hexed implant--The THA53 is used with an external hex platform)

Firm Action

Each USA customer was first contacted by telephone and then with a faxed, Urgent Medical Device Recall letter, dated 2/25/2008. Each International customer was first contacted by E-mail and then with a faxed letter. They were instructed to return the affected product to Biomet 3i.

Root Cause

Process control

Distribution Pattern

Worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072642BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTSBiomet 3i, Inc. · 2007-12-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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