Recalls / —
—#130153
Product
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 product code
- HTO — Reamer
- Device class
- Class 1
- Medical specialty
- Orthopedic
- Affected lot / code info
- Catalog numbers: 32-481000 Lot Numbers: 615860, 765230 Catalog Number: 32-481001 Lot Number Identification: 121450, 392410, 765250, 974290
Why it was recalled
Investigation determined that units supplied were missing the 4x21 degree helix angle.
Root cause (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Biomet, Inc.
- Address
- 56 E Bell Dr, Warsaw, Indiana 46581
Distribution
- Distribution pattern
- International Distribution in the countries of Netherlands, Europe, the Middle East, and Asia.
Timeline
- Recall initiated
- 2014-09-17
- Posted by FDA
- 2014-10-06
- Terminated
- 2015-07-14
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #130153. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.