RecallRadar

FDA Device recall Z-2090-2019

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

On 2019-08-07 the FDA classified a Class II recall of Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P by Encore Medical, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2090-2019
ClassificationClass II
Statusongoing
Initiated2018-09-19
Published2019-08-07
Last updated2026-09-13 11:55 UTC
CompanyEncore Medical
DistributionAZ, MO, MS, NY, OK, UT

Product

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

Reason

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.

Identifiers

code_infoLot # 262667L01

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2090-2019%22

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