FDA-Device2019-08-07Class II
Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P.
Encore Medical, Lp
Hazard
Manufacturing error, the drill bit shaft is unable to properly capture the drill bit pin. Failure of the drill bit shaft to capture the drill bit pin could result in the drill bit coming loose which could result in a delay in surgery or adverse patient reaction resulting in a revision surgery.
Sold states
US ( MS, NY, MO, OK, UT, AZ)
Affected count
21
Manufactured in
9800 Metric Blvd, N/A, Austin, TX, United States
Products
Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2090-2019Don't want to check this manually?
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