GXL Acetabular Liners Recalled Due to Non-Conforming Packaging
Exactech recalled 132 GXL acetabular liners (hip implant components) due to non-conforming bags that may accelerate device wear. Units were distributed worldwide to the US and 13 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 medical device recall with no reported adverse events or injuries. This involves packaging defects of an implanted orthopedic hip component that may cause accelerated wear, constituting a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Exactech, Inc. is recalling specific GXL acetabular polyethylene liners because they were packaged in non-conforming bags that may adversely impact the device and contribute to accelerated wear. The acetabular liner is a component used in hip implant surgery.
The recall affects 132 devices distributed worldwide, including throughout the United States and to 13 other countries: Argentina, Brazil, Chile, China, Colombia, Ecuador, Greece, Guatemala, India, Lebanon, Portugal, Puerto Rico, and Spain. Five different ACUMATCH product line variants are included in this recall.
If you have received or implanted one of these devices, contact your implant supplier or Exactech directly for guidance on next steps and device replacement options.
The recalled product
- Product
- GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE H, REF 138-36-08 b. ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE J, REF 138-36-09 c. ACUMATCH LINER 15 DEG 36MM ID, SIZE H, REF 132-36-08 d. ACUM
- Manufacturer
- Exactech, Inc.
- Hazard
- packaging-defect
- 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 138-36-08
- GUDID 10885862024787
- Serial Numbers: 638430
- 638433
- 638451
- 638462
- 638467
- b. REF 138-36-09
- GUDID 10885862024794
- Serial Numbers: 635279
- 635281
- c. REF 132-36-08
- GUDID 10885862023353
- Serial Numbers: 630606
- 630607
- 630609
- 630610
- 630611
- 630612
- 630613
Distribution
Distributed nationwide across the United States.
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