Recall Z-1000-2024— Howmedica Osteonics Corp.
Class II · Ongoing
Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2023-12-22. FDA's recall record names no specific 510(k) clearance for this event. Product: HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, sterile surgical instruments used during hip arthroplasty. Reason: 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.
- Recalling firm
- Howmedica Osteonics Corp.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-12-22
- Firm location
- Mahwah, NJ, United States
Product description
HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.