Surgical hip instruments recalled due to compromised sterility packaging
Howmedica Osteonics is recalling HRIS ACET CUP surgical instruments used in hip replacement surgery due to failed package seal integrity testing. The recall affects lot-numbered units distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Compromised sterility on surgical instruments is a risk-of-harm product. No illnesses or injuries are reported in the source, placing this at Score 3 per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Howmedica Osteonics Corp. is recalling the HRIS ACET CUP CUT TIP 26X140 (Part Number: 6210-5-100), a single-use sterile surgical instrument used during hip arthroplasty (hip replacement surgery). The recall affects units distributed worldwide, including the United States and 17 additional countries, identified by specific lot numbers.
The product failed to meet acceptance criteria for seal integrity and package integrity testing of both the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch. This compromise of the sterile barrier means the instruments may not maintain their sterility, potentially putting patients at risk of infection during surgery.
The FDA classified this as a Class II recall. Healthcare facilities should verify whether they have received units with the affected lot numbers and take appropriate action to ensure only sterile instruments are used in surgical procedures.
The recalled product
- Product
- HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty
- Manufacturer
- Howmedica Osteonics Corp.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Howmedica Osteonics Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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