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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83037

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 19, 2018
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Encore Medical, Lp

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-2090-2019
Recall number
Z-2090-2019
Initiated
September 19, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Encore Medical, Lp
Quantity
21

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Manufacturing error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot # 262667L01

Distribution pattern

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