FDA recall Z-2090-2019

Product

Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P.

Reason for recall

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.

Distribution

US ( MS, NY, MO, OK, UT, AZ)

Key facts

Status

Ongoing

Initiation date

2018-09-19

Report date

2019-08-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2090-2019