Smith & Nephew recalls specific bone plate models due to incorrect labeling causing potential use of wrong plate size during surgery. Affected units include VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE with a Stout plate.
Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-MOD 2.0MM STOUT PLATE 8 HOLE and vice versa
Smith & Nephew is recalling certain bone plating systems because some units were incorrectly labeled. This could lead to using the wrong plate size during surgery, which might cause complications. Affected products include specific models with lot number 16KM10662C.
The recalled bone plates were incorrectly labeled as a straight plate when they are actually a stout plate. Using the wrong plate size during surgery could lead to improper bone fixation and potential complications.
Orthopedic surgeons and medical professionals who use Smith & Nephew bone plating systems for small bone repairs. Those using the specific model with lot number 16KM10662C are most at risk.
Check for the product name 'VLP(R) Mini-Mod Small Bone Plating System' or 'EVOS(R) Mini Plating system' with the lot number 16KM10662C. The specific plate model is labeled as 2.0MM STRAIGHT PLATE 8 HOLE but contains a Stout plate.
Look for the lot number 16KM10662C on the bone plate packaging or label.
The recalled model is the VLP(R) Mini-Mod Small Bone Plating System with the lot number 16KM10662C, labeled as 2.0MM STRAIGHT PLATE 8 HOLE but containing a Stout plate.
Using the wrong plate size during surgery could lead to improper bone fixation and potential complications.
The recall does not require stopping use; it's a labeling error that needs verification of the specific lot number.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-0397-2018 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-0397-2018 from Smith & Nephew. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
