Recall Z-1000-2024 ยท LXH Orthopedic Manual Surgical Instrument
Howmedica Osteonics Corp.
HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, sterile surgical instruments used during hip arthroplasty
| Date | Feb 6, 2024 (initiated Dec 22, 2023) |
| Status | Open, Classified |
| 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 |
| Root cause | Package design/selection |
| Action | Stryker issued Urgent Medical Device Recall (UMDR) PFA 3285098 was issued by third party Sedgwick on 22/DEC/2023 via UPS 2-day air. OUS customer notification will be issued at the country level. Letter states reason for recall, health risk and action to take: 1. Please inform users of this Urgent Medical Device Correction and forward this notice to all individuals who need to be made aware. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Dispose of all affected products listed in the Part an |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.