Smith & Nephew recalls certain Mini-Fragment Plating Systems due to incorrect labeling of 2.0mm bone plates, which could lead to improper surgical use if mixed up.
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 specific bone plating systems that have incorrect labeling of 2.0mm plates. This could cause surgical errors if the wrong plate type is used during procedures.
The recalled systems contain plates labeled incorrectly as one type but are actually another. This mix-up could lead to improper surgical application if the wrong plate is used during procedures.
Surgical professionals and patients who have received the specific bone plating systems with incorrect labeling. Those using the systems for internal fixation of small bones are most at risk.
Check for the product name 'Smith & Nephew Mini-Fragment Plating System' with the model 'VLP(R) Mini-Mod Small Bone Plating System' or 'EVOS(R) Mini Plating system'. Look for the lot number 15GM08498C on the packaging.
Look for the lot number 15GM08498C on the packaging to confirm if the product is affected.
The recalled product is the Smith & Nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, or EVOS(R) Mini Plating system with the lot number 15GM08498C.
Check for the lot number 15GM08498C on the packaging. The product is labeled incorrectly as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE but contains a VLP MINI-MOD 2.0MM STOUT PLATE 8 HOLE.
The recall does not specify a remedy, so contact Smith & Nephew directly for guidance.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-0396-2018 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-0396-2018 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.