Z-2090-2019 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 7, 2019
- Initiation Date
- September 19, 2018
- Termination Date
- N/A
- 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