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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 41
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
Related recalls
Same manufacturer · IMPLANTCAST GMBH
See all →- HighImplantcast Recalls Hip Implant Inserts Due to Retaining Ring Mounting Risk
FDA (Devices) · 2018-08-01
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