Recall Z-2090-2019— Encore Medical, Lp
Class II · Ongoing
Class II FDA medical device recall by Encore Medical, Lp, initiated 2018-09-19. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Encore Medical, Lp
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2018-09-19
- Firm location
- Austin, TX, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.