Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P.
- Recall Initiated
- September 19, 2018
- Recall Number
- Z-2090-2019
- Quantity
- 21
- Firm Location
- Austin, TX
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
US ( MS, NY, MO, OK, UT, AZ)
Lot / Code Info
Lot # 262667L01
Root Cause
Nonconforming Material/Component
Action Taken
On 9/19/2018 the firm emailed an "Urgent Field Safety Notice" letter to their consignees. The Field Safety Notice letter asked the customers to do the following: 1.Contact their customer service to request a RMA for return and exchange. 2.If the customer does not have the drill shaft or the number of sets identified, please contact Joan Busick at andra.busick@djdoglobal.com. 3. If the customer has questions they should contact Teffany Hutto by phone at (512) 834-6255.