The Recall Desk
HighFDA (Devices)·Z-2050-2021·Announced 2021-07-21

EcoFit Cementless Acetabular Cup Plugs May Loosen During Hip Surgery

Central hole cover plugs on EcoFit cementless acetabular cups may come loose during surgical implantation, potentially extending operation time or requiring revision surgery. Fifty-one units in Florida and Texas are affected.

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 medical device with a risk of surgical complication (loose components requiring revision surgery), but no injuries or hospitalizations are reported in the source. The rubric applies Score 3 for risk-of-harm products where injury has not yet been reported.

Plain-English summary

The FDA is recalling EcoFit cementless acetabular cups (sizes 46mm through 68mm) manufactured by IMPLANTCAST GMBH. These are socket components implanted during hip replacement surgery. A total of 41 units have been distributed in Florida and Texas.

During surgical implantation of the cup into bone, the central hole cover plugs may come loose from the cup. This could result in extended operation duration or may require a revision operation to correct. The issue may be influenced by variations in bone quality, such as osteosclerosis.

The manufacturer is updating the instructions for use and surgical technique documentation with warning notes alerting surgeons to this risk and the importance of bone quality assessment. Patients who have received this implant or providers using this device should consult with the treating surgeon regarding any concerns.

The recalled product

Product
EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit cup cementless 46mm dia incl. central hole cover; 02200048 /EcoFit cup cementless 48mm dia incl. central hole cover; 02200050 /EcoFit cup cementless 50mm dia incl. central hole cover; 02200052 /EcoFit
Manufacturer
IMPLANTCAST GMBH
Category
Medical Device — Hip Implant
Hazard
  • plug-loosening
  • device-failure
  • surgical-complication

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 (14)

  • UDI: 04048844005368 Lot Numbers: 1736252001
  • 1736252003
  • 1736252004
  • 1736252006
  • 1736252007
  • 1736252008
  • 1736252010
  • 18481C0027
  • 18481C0010
  • 18481C0004
  • 18481C0013
  • 18481C0005
  • 18481C0024
  • 02200048 /EcoFit¿ cup cementless ¿ 48mm incl. central hole cover

Distribution

Distributed nationwide across the United States.

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