GXL Acetabular Liners Packaged Improperly May Experience Accelerated Wear
Exactech is recalling certain GXL acetabular hip implant liners because non-conforming packaging may cause accelerated wear. No injuries have been reported.
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 a hip implant component with potential for accelerated wear due to packaging defects. Although no illnesses or injuries have been reported, the hazard represents a risk-of-harm to implanted patients, as implant degradation and wear can lead to serious complications requiring surgical revision.
Plain-English summary
Exactech, Inc. is recalling specific GXL acetabular polyethylene liners used as hip implant components because they were packaged in non-conforming bags that may negatively affect the implant and lead to accelerated wear.
The recall involves 3,793 devices distributed worldwide, including throughout the United States and to Argentina, Brazil, Chile, China, Colombia, Ecuador, Greece, Guatemala, India, Lebanon, Portugal, Puerto Rico, and Spain. The affected products are specific GXL Neutral Liners and Novation GXL Lipped Liners identified by their product numbers and serial number ranges.
No adverse events or injuries have been reported. Patients who received these implants should consult with their healthcare provider. Healthcare providers should contact Exactech for information on patient management and recall details.
The recalled product
- Product
- GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132
- 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. 130-28-50
- GUDID 10885862022059
- Serial Numbers: 1784995
- 1784996
- 1784998
- 1785000
- 1785002
- 1785003
- 1785006
- 1785011
- 1785012
- 1785013
- 1785015
- 1785016
- 1785017
- 1785018
- 1785022
- 1785024
- 1785026
- 1785027
Distribution
Distributed nationwide across the United States.
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