Hip Replacement Component Recalled for Potential Device Failure Risk
Biomet is recalling 81 units of a hip replacement component due to potential device failure that could require additional surgery. The affected device is the Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A.
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: This is a risk-of-harm medical device recall where device failure could necessitate surgical intervention. Although no injuries or illnesses have been reported and the hazard is described as potential rather than confirmed, the seriousness of requiring revision surgery places this at High severity.
Plain-English summary
Biomet, Inc. is recalling the Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A (50 MM), Item Number 11-301310. A total of 81 units with the affected lot numbers have been distributed nationwide in the United States.
The device could potentially exhibit chatter in the inner taper, which may lead to fretting corrosion and device failure inside the body. If this occurs, patients may require additional surgical intervention to revise or replace the component.
Healthcare providers should identify patients who received this device using the lot numbers and UDI codes listed in the recall notice. Patients should contact their healthcare provider if they have questions about whether they received an affected device.
The recalled product
- Product
- Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 50 MM Item Number: 11-301310
- Manufacturer
- Biomet, Inc.
- Affected units
- 81
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 recalled by Biomet, Inc. 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.
See all 17 products in this recall →Related recalls
Same manufacturer · Biomet, Inc.
See all →- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recall for Packaging Damage
FDA (Devices) · 2026-08-12
Same hazard · device failure
See all →- HighStryker Recalls XCEL Bladeless Trocar Due to Cracking Risk
FDA (Devices) · 2026-09-23
- SevereMedline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighCoaptium Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
Similar recalls
- HighHip implant revision system recalled due to inadequate coating adhesion
FDA (Devices) · 2022-03-02
- SevereZimmer Biomet Recalls Modular Hip Head Components Due to Sizing Errors
FDA (Devices) · 2018-05-09
- ModerateZimmer Biomet Recalls ARCOS Modular Revision Hip System Femoral Stems
FDA (Devices) · 2018-08-22
- HighBiomet Recalls RingLoc Hip System Components Due to Endotoxin Levels
FDA (Devices) · 2020-06-03
- SevereEncore Medical Recalls Exprt Precision System Hip Implant Components
FDA (Devices) · 2019-04-17
- ModerateZimmer Biomet Recalls Echo Hip Stems Due to Potential Component Comingle
FDA (Devices) · 2018-08-22