GXL Acetabular Liners Recalled Due to Non-Conforming Packaging and Accelerated Wear Risk
Exactech's GXL acetabular hip implant liners are being recalled because they were packaged in non-conforming bags that may cause accelerated wear of the devices.
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: FDA Class II recall without reported hospitalizations or injuries. The hazard—accelerated wear from non-conforming packaging—is a prospective device-durability risk without confirmed patient harm. Per the rubric criteria, Class II without injury reports and theoretical hazard scores at the High level.
Plain-English summary
Exactech, Inc. is recalling 2,319 GXL acetabular liners, which are components used in hip replacement surgeries. The affected devices include multiple product lines across different sizes and reference numbers, as specified by the FDA.
The recall was initiated because these devices were packaged in non-conforming bags, which may adversely impact the devices and contribute to accelerated wear. This packaging defect could potentially affect the performance and durability of the hip implants over time.
The affected devices were distributed worldwide, including throughout the United States and internationally to countries such as Argentina, Brazil, Chile, China, Colombia, Ecuador, Greece, Guatemala, India, Lebanon, Portugal, Puerto Rico, and Spain. Patients who have received these implants should consult with their healthcare providers about their individual risk and whether any monitoring or follow-up is needed.
If you have one of these implants, contact your orthopedic surgeon or healthcare provider to discuss your specific situation and any recommended actions.
The recalled product
- Product
- GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d.
- Manufacturer
- Exactech, Inc.
- Hazard
- accelerated-wear
- packaging-defect
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 (20)
- a. REF 134-28-41
- GUDID 10885862023971
- Serial Numbers: 1152706
- 1152707
- 1152709
- 1152711
- 1152712
- 1152713
- 1152714
- 1152716
- 1152717
- 1152719
- 1152721
- 1152722
- 1152724
- 1152725
- 1338587
- 1338588
- 1338589
- 1338590
Distribution
Distributed nationwide across the United States.
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