Reported Aug 7, 2019 · Ongoing
Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P.
Encore Medical, LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Encore Medical, Lp · 9800 Metric Blvd · Austin, TX · 78758-5445
Is this the product you have?
- Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P.
- Lot codes and dates
- Lot # 262667L01
- Amount recalled
- 21
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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