Data Foundry

Medical device recalls 2019

Flexible Drill Shaft — Class II medical device recall Z-2090-2019

Ongoing recall by Encore Medical, Lp, reported 2019-08-07, distributed in AZ, MO, MS, NY, OK, UT. Manufacturing error, the drill bit shaft is unable to properly capture the drill bit pin. Failure of the drill

Recall numberZ-2090-2019
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmEncore Medical, Lp, Austin, TX, United States
Recall initiated2018-09-19
Classified2019-07-27
Reported by FDA2019-08-07
DistributedAZ, MO, MS, NY, OK, UT
Quantity21
Lot numbers262667L01
Model numbers803-05-239RX

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2090-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.