Arcos Hip System Cones Recalled for Potential Inner Taper Corrosion
Biomet recalled 11 Arcos Modular Revision Hip System proximal cones due to potential inner taper fretting corrosion and device failure that could require surgical intervention. Affected units distributed nationwide.
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 of an orthopedic implant with potential for device failure requiring surgical intervention. No injuries or illnesses are reported in the source text, and the hazard is described as potential rather than confirmed. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Biomet, Inc. has recalled 11 units of the Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 70 MM (Item Number 11-301322, Lot 678990). The recall was issued because the proximal cone bodies could potentially exhibit chatter and fretting corrosion in the inner taper of the implant, which could result in device failure while the implant is in a patient's body.
Device failure of the hip implant could require surgical intervention to remove or replace the implant. The affected units were distributed nationwide in the United States.
Patients who have received this implant should consult with their healthcare provider or surgeon to determine whether their device is included in this recall. Healthcare providers should not use the recalled inventory.
The recalled product
- Product
- Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 70 MM Item Number: 11-301322
- Manufacturer
- Biomet, Inc.
- Hazard
- inner-taper-corrosion
- device-failure
- surgical-intervention-required
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers/UDI : 678990 (01)00880304473751(17)310407(10)678990
Distribution
Distributed nationwide across the United States.
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