Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41-23, b) 350-42-03 recall — FDA Z-0588-2024
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Overview of recall records associated with Exactech, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 113.
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.
The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
This page summarizes recall records in which the official source identifies Exactech, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.