Reported Mar 9, 2022 · Terminated
The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The…
Wright Medical Technology, Inc.
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: Wright Medical Technology, Inc. · 1023 Cherry Rd · Memphis, TN · 38117-5423
Is this the product you have?
- The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the plates are aligned to assure the screws do not touch. The various plates model numbers differ from each other through among other things different curvatures, material strengths, lengths, number of plate holes and through different grades and bridge widths
- Lot codes and dates
Model No. DCS2825126Lot No. 11012187061566009
- Amount recalled
- 12 units
Why it was recalled
Product was labelled with the incorrect manufacturing and distribution dates.
This product could cause temporary or reversible health problems — stop using it.
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