Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-2
FDA device recall Z-1167-2025 · posted 2025-02-12 · Open, Classified
Recall details
- Recalling firm
- Exactech, Inc.
- Reason for recall
- Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
- Action taken
- On 12/31/2024, the firm sent an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" letter via FedEx to customers initially informing them that the firm was recalling specific hip polyethylene liner lots that were inadvertently packaged without the ethylene vinyl alcohol (EVOH) layer in the innermost bag. An updated customer notification letter was communicated to affected customer via email on 01/17/2025. Customers are instructed to: -Immediate Discontinuation: Immediately discontinue use of all affected products -Quarantine and Return: Segregate and quarantine affected products and arrange for their return to Exactech. The Recall Confirmation Form section of this communication provides product return instructions. Clinical Guidance: 1. Patient Monitoring: Surgeons should regularly monitor patients with affected devices for potential risks such as device wear, failure, component cracking or fracture, new or worsening pain, bone loss and/or swelling, as per the instructions for use. 2. Diagnostic Considerations: Diagnostic imaging, such as X-rays, may be considered if device failure is suspected. 3. Revision Considerations: Revision of well-functioning devices is not recommended for patients. 4. Resources: Healthcare providers and patients with questions can access educational resources on our website exac.com/recall-information and use the device serial look-up tool. Public Contact - 352-377-1140 or email matt.collins@exac.com
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- LPH
- Quantity affected
- 1446
- Distribution
- U.S.: AR, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, MN, NV, NY, OH, OK, PR,SC, TN, TX and VA O.U.S.: Argentina, Colombia, Germany, Guatemala, Japan and Spain
- Date initiated
- 2024-12-31
- Date posted
- 2025-02-12
- Location
- Gainesville, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Alteon Acetabular Cup System (K182502) | Exactech, Inc. | 2019-03-13 |