Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint rep
FDA device recall Z-0021-2015 · posted 2014-10-06 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- Investigation determined that units supplied were missing the 4x21 degree helix angle.
- Action taken
- 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
- Status
- Terminated
- Product code
- HTO
- Quantity affected
- 4
- Distribution
- International Distribution in the countries of Netherlands, Europe, the Middle East, and Asia.
- Date initiated
- 2014-09-17
- Date posted
- 2014-10-06
- Date terminated
- 2015-07-14
- Location
- Warsaw, IN
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