Z-2090-2019 Class II Ongoing
FDA device recall Z-2090-2019 was initiated by Encore Medical, Lp on Sep 19, 2018 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 21.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 7, 2019
- Initiation Date
- Sep 19, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21
Product Description
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 Pattern
US ( MS, NY, MO, OK, UT, AZ)
Code Information
Lot # 262667L01
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2090-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026