Hip Arthroplasty Surgical Instruments Recalled for Sterile Barrier Failure
Howmedica Osteonics Corp. is recalling hip arthroplasty surgical instruments after their sterile packaging failed integrity testing. Units with compromised packaging were distributed worldwide.
What this means for you
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: This is an FDA Class II recall with no reported illnesses or injuries. Per the rubric, when no illnesses/injuries are reported and the hazard is theoretical, the score is at most 3. This is a risk-of-harm product (sterile surgical instruments) where injury has not yet been reported, placing it at High (3).
Plain-English summary
Howmedica Osteonics Corp. is recalling the HRIS ACET CUP CUT TIP 32X140 (Part Number: 6210-5-200rker), a single-use sterile surgical instrument used during hip arthroplasty procedures.
The recall was initiated after testing revealed that certain units failed to meet acceptance criteria for sterile barrier integrity. The Sterile Barrier Outer Pouch and Protective Barrier Inner Pouch of affected units did not maintain proper integrity, which compromises the product's sterility.
The affected products were distributed worldwide, including throughout the United States and to Argentina, Australia, Brazil, Canada, Chile, China (Hong Kong), Colombia, Italy, Japan, Malaysia, Netherlands (Venlo), Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, and the United Kingdom. Affected lot numbers are specified in the official recall notice.
Healthcare providers and patients who may have been affected should contact Howmedica Osteonics Corp. or review the recall notice for specific lot numbers. Affected units should not be used for surgical procedures.
The recalled product
- Product
- HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, sterile surgical instruments used during hip arthroplasty
- Manufacturer
- Howmedica Osteonics Corp.
- Hazard
- sterility-failure
- packaging-defect
Distribution
Distributed nationwide across the United States.
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