Recall Z-2090-2019 ยท HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Encore Medical, Lp
Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P.
| Date | Sep 19, 2018 |
| Status | Open, Classified |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 21 |
| Distribution | US ( MS, NY, MO, OK, UT, AZ) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.