Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P.
Reported: August 7, 2019 Initiated: September 19, 2018 #Z-2090-2019
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.
Details
- Recalling Firm
- Encore Medical, Lp
- Units Affected
- 21
- Distribution
- US ( MS, NY, MO, OK, UT, AZ)
- Location
- Austin, TX
Frequently Asked Questions
What product was recalled? ▼
Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P.. Recalled by Encore Medical, Lp. Units affected: 21.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 7, 2019. Severity: Moderate. Recall number: Z-2090-2019.
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