DARCO Locking Bone Plate System Recalled for Incorrect Manufacturing and Distribution Dates
Wright Medical Technology is recalling the DARCO Locking Bone Plate System because product labels contain incorrect manufacturing and distribution dates. The recall affects 12 units distributed to Japan and the United Kingdom.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall involving labeling with incorrect manufacturing and distribution dates. No reported illnesses, injuries, or other harm has been documented. The hazard is a documentation and labeling error rather than a defect affecting device safety or function.
Plain-English summary
The DARCO Locking Bone Plate System is a surgical bone plate system manufactured from biocompatible titanium with either 2.7mm or 3.5mm locking screws. The plates are designed with a rhombus shape and use intersecting screw pairs.
Wright Medical Technology, Inc. is recalling this device because it was labeled with incorrect manufacturing and distribution dates. The recall affects 12 units of Model No. DCS2825126, Lot No. 11012187061566009. The affected units were distributed internationally to Japan and the United Kingdom.
Healthcare providers and facilities with this device should verify their inventory records and contact Wright Medical Technology, Inc. for corrected labeling information and guidance.
The recalled product
- Product
- 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…
- Manufacturer
- Wright Medical Technology, Inc.
- Hazard
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model No. DCS2825126
- Lot No. 11012187061566009
Distribution
Distribution scope not specified by the agency.
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