FDA Device recall Z-2090-2019
Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P
- FDA Device
- Class II
- ongoing
- Published 2019-08-07
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
| Agency | FDA Device |
|---|---|
| Recall number | Z-2090-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-09-19 |
| Published | 2019-08-07 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Encore Medical |
| Distribution | AZ, 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_info | Lot # 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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