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Terminated

Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.

FDA Recall Z-0021-2015 · Posted 2014-10-06

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeHTO
Date Initiated2014-09-17
Date Terminated2015-07-14
Product Quantity4

Reason for Recall

Investigation determined that units supplied were missing the 4x21 degree helix angle.

Firm Action

On September 17, 2014, "URGENT MEDICAL DEVICE RECALL NOTICE" was sent to the consignee Biomet Global Supply Chain Center (GSCC) by email and FedEx. GSCC notified all of the customers within Europe, the Middle East, and Asia that received the affected product. The recall notification included a description of the reason for recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, call (574) 372-1570.

Root Cause

Process control

Distribution Pattern

International Distribution in the countries of Netherlands, Europe, the Middle East, and Asia.

Official Source

View FDA Recall →

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

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