Exactech Vantage Mobile Bearing Tibial Inserts Recalled Due to Vacuum Loss
Exactech is recalling Vantage Mobile Bearing Tibial Inserts due to loss of vacuum in the innermost vacuum bag. Three complaints involving four devices have been reported.
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 or injuries. The hazard—loss of vacuum in medical device packaging—represents a theoretical risk-of-harm where actual injury has not been reported, fitting the High (Score 3) criterion.
Plain-English summary
Exactech, Inc. is recalling Vantage Mobile Bearing Tibial Inserts (Catalog Numbers 350-41-23 and 350-42-03) used in knee replacement surgery. These devices are orthopedic components used in total knee arthroplasty.
The recall was initiated because Exactech has received 3 complaints related to a loss of vacuum in the innermost vacuum bag of the affected inserts.
The affected devices were distributed in the United States (New York, Texas, Indiana, Illinois, Minnesota, Kentucky, Virginia, Maryland, Tennessee, Georgia, New Hampshire, Maine, South Carolina, Nevada, Florida, and Arkansas) and internationally (Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, and the United Kingdom). Specific affected serial numbers are: Catalog Number 350-41-23 (A658148) and Catalog Number 350-42-03 (A688867, A688880, A688864, A688868, A688870, A688872, A688873, A688876, A688879, A688881, A688882).
The recalled product
- Product
- Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41-23, b) 350-42-03
- Manufacturer
- Exactech, Inc.
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 (15)
- a) 350-41-23
- GTIN none
- Serial Numbers: A658148
- b) 350-42-03
- Serial Numbers: A688867
- A688880
- A688864
- A688868
- A688870
- A688872
- A688873
- A688876
- A688879
- A688881
- A688882
Distribution
Part of a larger recall action
This product is one of 12 recalled by Exactech, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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