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Recall Observatory FDA recall evidence

Device product

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

Z-2090-2019

September 19, 2018

Class II

Product summary

Firm
Encore Medical, Lp
Event
Event 83037
Status
Ongoing
Classification
Class II
Quantity
21
Official record key
device-enforcement:Z-2090-2019

Official wording

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.

Code information: Lot # 262667L01

Distribution pattern: US ( MS, NY, MO, OK, UT, AZ)

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    Manufacturing error