Smith & Nephew recalls STIKTITE coated stems with incorrect size labeling. The product is size -1 but labeled as size 1. Affected units include specific batch numbers.
Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1"
Smith & Nephew is recalling a specific type of surgical stem due to a label error that incorrectly identifies the size as "1" instead of "-1". This could lead to improper use if the wrong size is selected for a procedure.
The label error means the product is size -1 but appears as size 1. This could cause improper fitting during surgical procedures if the wrong size is used, potentially leading to complications.
Surgical professionals and patients using Smith & Nephew STIKTITE coated stems with the specific batch numbers listed. Those most at risk are individuals who have the product labeled as size 1 but it is actually size -1.
Check for the product name 'smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE' on the label. Affected units have specific batch numbers: 11AM15163U, 11AM15184T, 11CM01097U, 15MM06466, 16EM13018, 16EM13035, and 18CM08027.
Look for the product name and batch numbers listed in the recall notice to confirm if your item is affected.
The product was incorrectly labeled as size "1" instead of size "-1" in the packaging, which could lead to improper use during surgical procedures.
Affected batch numbers are 11AM15163U, 11AM15184T, 11CM01097U, 15MM06466, 16EM13018, 16EM13035, and 18CM08027.
No action is required if your product is not listed in the affected batch numbers. Only check the label and batch numbers to confirm if it is affected.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-1028-2019 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-1028-2019 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.
