Nextremity Solutions recalls Stratum Lapidus Plate (Part No. STRM-LAP-SMR) due to incorrect plate type. This could cause improper bone fixation. Affected units have UDI 00817701025467.
The product contains a different plate than indicated by the package labeling. The product is labeled as a right plate but contains a left plate.
Nextremity Solutions is recalling a specific Stratum Lapidus Plate model because it contains a left plate instead of the labeled right plate. This mismatch could lead to improper bone fixation during medical procedures.
The plate is labeled as a right side plate but contains a left side plate. This mismatch could cause improper alignment during bone fixation procedures, potentially leading to complications in surgical outcomes.
Patients using the Stratum Foot Plating System for bone fixation may be affected. Medical professionals who installed the plate are at higher risk due to the critical nature of bone surgery.
Check for the product name 'Stratum Lapidus Plate - Small Rt' with part number STRM-LAP-SMR. Affected units have a unique device identifier (UDI) starting with 00817701025467.
Verify the plate's part number and unique device identifier (UDI) to confirm if it matches the recalled model.
The product contains a left plate instead of the labeled right plate, which could cause improper bone fixation during medical procedures.
The official recall notice does not specify a remedy or action steps for affected users.
Check for the product name 'Stratum Lapidus Plate - Small Rt' with part number STRM-LAP-SMR and unique device identifier (UDI) 00817701025467.
We’ve drafted a message you can send Nextremity Solutions to request your refund or repair — edit it as you like.
Subject: Recall Z-1127-2020 — Nextremity Solutions Nextremity Solutions Hello, I own a Nextremity Solutions that is covered by recall Z-1127-2020 from Nextremity Solutions. 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.
