The Recall Desk
HighFDA (Devices)·Z-2236-2024·Announced 2024-07-10

Acumatch L-Series Hip Implant Liners Recalled for Packaging Defect

Exactech is recalling Acumatch L-Series hip implant liners because some units were packaged without the specified protective ethylene vinyl alcohol (EVOH) layer, which is required for proper device protection.

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 with no reported illnesses, injuries, or hospitalizations. The hazard—a missing protective packaging layer (EVOH)—creates a risk of harm to patients with implanted devices, but no actual adverse events have been reported. Per the rubric, risk-of-harm products without reported injury receive a High severity score.

Plain-English summary

Exactech Inc. is recalling Acumatch L-Series 22mm BIPOLAR hip implant liners, which are devices used in hip replacement surgeries. This recall affects seven item numbers (sizes L through T) across 589 total units.

Between 2004 and August 2021, some of these liners were packaged without the specified ethylene vinyl alcohol (EVOH) protective layer. The company used two different packaging materials during this period: some units were correctly packaged with LDPE, Nylon, and EVOH, while others were packaged with only LDPE and Nylon, lacking the protective EVOH component.

The affected devices were distributed worldwide, including in Puerto Rico and countries such as Great Britain and Japan. This is a Class II FDA recall. Patients and healthcare providers with these devices should refer to the lot numbers provided by Exactech to determine if their units are affected, then contact their healthcare provider or Exactech for further guidance.

The recalled product

Product
Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T
Manufacturer
Exactech, Inc.
Category
Medical Device — Hip Implant
Hazard
  • packaging-defect
  • protective-layer-missing

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) 100-22-19
  • UDI/DI 10885862009302
  • Lot Numbers: 2051878
  • 2051881
  • 2051883
  • 2051884
  • 2051897
  • 2051899
  • 2051904
  • 2051906
  • 2051901
  • 2583739
  • 2583740
  • 2583741
  • 2583742
  • 2583743
  • 2583744
  • 2583745
  • 2583746
  • 2583747

Distribution

Distribution scope not specified by the agency.

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