GXL Acetabular Liners Recalled Due to Non-Conforming Packaging
Exactech is recalling certain GXL acetabular liners packaged in non-conforming bags that may cause accelerated wear of the hip implant component. No injuries have been reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—accelerated wear from non-conforming packaging is a durability concern rather than an acute safety threat. Per the rubric, when no illnesses/injuries are reported and the hazard is theoretical, the score is at most 3. This packaging defect qualifies as a Moderate recall.
Plain-English summary
Exactech, Inc. is recalling certain GXL acetabular liners, which are components of hip implants. The recalled units were packaged in non-conforming bags.
The non-conforming packaging may adversely impact the device and contribute to accelerated wear of the acetabular liner over time.
The recall affects 58,158 devices distributed worldwide, including in the United States and multiple countries (Argentina, Brazil, Chile, China, Colombia, Ecuador, Greece, Guatemala, India, Lebanon, Portugal, Puerto Rico, and Spain). Specific product reference numbers, lot numbers, and serial numbers are documented in the FDA recall notice Z-1729-2022.
Patients with these implants should consult their orthopedic surgeon. Healthcare providers should review the FDA recall notice for detailed product information and serial numbers to identify affected units. Exactech is providing additional information and support to healthcare facilities.
The recalled product
- Product
- GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER, NEUTRAL, 28MM ID, GROUP 1 CUPS, REF 130-28-51 b. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 2 CUPS, REF 130-32-52 c. NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 3 CUPS, RE
- 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 130-28-51
- GUDID 10885862022066
- Serial Numbers: 1018800
- 1018801
- 1018805
- 1018806
- 1018808
- 1018809
- 1018810
- 1018814
- 1018815
- 1018816
- 1018817
- 1018818
- 1018823
- 1018824
- 1018832
- 1018834
- 1018835
- 1018836
Distribution
Distributed nationwide across the United States.
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