Biomet recalls 9mm Shoulder Mini Humeral Stem (Model 11362: Lot 659260) due to misidentification as 15mm. This could lead to improper joint fitting and potential complications during surgery.
A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem.
Biomet is recalling a specific shoulder implant model because it was mistakenly labeled as 9mm when it's actually 15mm. Using the wrong size could cause improper joint fitting and potential complications during surgery.
The implant was mislabeled as a 9mm size when it's actually a 15mm size. This mismatch could lead to improper joint fitting during surgery, potentially causing complications like instability or improper movement.
Orthopedic surgeons and patients who have received this specific shoulder implant model (Model 113629, Lot 659260) are affected. Surgeons using the product for joint replacements are most at risk.
Check for the model number 113629 and lot number 659260 on the implant. The product was sold as part of the Comprehensive Shoulder System for joint replacements.
Verify the model number (113629) and lot number (659260) on the implant to confirm it's the recalled item.
The recall is due to misidentification, not inherent danger. Using the correct size is critical for proper joint function.
Look for model number 113629 and lot number 659260 on the implant. The product was sold for joint replacements.
The recall does not require returning the implant; it only requires verification of the model and lot numbers.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1543-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1543-2020 from Biomet. 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.
