HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty
Reported: February 14, 2024 Initiated: December 22, 2023 #Z-0999-2024
Product Description
HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty
Reason for Recall
Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility
Details
- Recalling Firm
- Howmedica Osteonics Corp.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Brazil, Canada, Chile, China (Hong Kong), Columbia, Italy, Japan, Malaysia, Netherlands (Venlo), Slovenia, S. Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom.
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty. Recalled by Howmedica Osteonics Corp..
Why was this product recalled? ▼
Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 14, 2024. Severity: Moderate. Recall number: Z-0999-2024.
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