GXL Acetabular Liners Recalled Due to Improper Packaging and Accelerated Wear
Exactech is recalling 136 GXL acetabular liners used in hip implants due to non-conforming packaging that may cause accelerated wear. The devices were distributed worldwide to multiple countries.
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 of orthopedic hip implants, which are high-risk devices implanted in patients. The non-conforming packaging may cause accelerated device wear and potential failure requiring revision surgery. No injuries or illnesses have been reported in the source.
Plain-English summary
Exactech, Inc. is recalling 136 GXL acetabular liners, components used in orthopedic hip implants. These devices were packaged in non-conforming bags during manufacturing, which may adversely impact the device and contribute to accelerated wear.
The affected devices were distributed worldwide, including to the United States and the following countries: Argentina, Brazil, Chile, China, Colombia, Ecuador, Greece, Guatemala, India, Lebanon, Portugal, Puerto Rico, and Spain. Specific serial numbers for each product line have been identified and documented by the FDA.
Patients and healthcare providers should verify whether they received affected devices by checking the product reference numbers and serial numbers against the FDA recall notice. Individuals who received these implants should consult their orthopedic surgeon to determine appropriate next steps.
The recalled product
- Product
- GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 15 DEGREE LINER 22MM SZ C, REF 132-22-03 b. ACUMATCH 15 DEGREE LINER 28MM SZ D, REF 13-28-04
- Manufacturer
- Exactech, Inc.
- Hazard
- improper-packaging
- accelerated-wear
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 132-22-03
- GUIDID 10885862022882
- Serial Numbers: 1191262
- 1191263
- 1191264
- 1191265
- 1191266
- 1191267
- 1191268
- 1191269
- 1191270
- 1191271
- 1191272
- 1191273
- 1264678
- 1264679
- 1264680
- 1264681
- 1264682
- 1264683
Distribution
Distributed nationwide across the United States.
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