Lower riskMedical device recall · FDA · Published February 17, 2020
Biomet Comprehensive Shoulder System Mini Humeral Stem 9mm Misidentified as 15mm - Risk
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.
“Biomet Comprehensive Shoulder System Mini Humeral Stem 9mm Misidentified as 15mm - Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65830-biomet-comprehensive-shoulder-system-mini-humeral-stem-9mm-misidentified-as. Based on FDA recall #Z-1543-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1543-2020%22&limit=1).
The FDA announced on Feb. 17, 2020, that Biomet, Inc. voluntarily recalled 14 units of the Comprehensive Shoulder System Mini Humeral Stem 9mm (Model No. 113629) due to misidentification hazards.
How to tell if you have it
Brand: Biomet
Product: Comprehensive Shoulder System Mini Humeral Stem 9mm
Model No.: 113629
Lot No.: 659260
UDI Number: (1)00880304462649(17)290814(10)659260
Quantity: 14 units
Distribution: Canada, Japan, Netherlands, South Korea
The hazard
The recall involves a 15mm Shoulder Mini Humeral Stem being misidentified as a 9mm Shoulder Mini Humeral Stem.
Context
GovInfoNow's records show Biomet, Inc. has 28 other recalls on record since Feb. 28, 2018. Recent brand recalls include the July 1, 2026 Intramedullary Bone Saw Blade Recall for sterile packaging risk and the Sept. 23, 2025 ZipT recall for a missing button risk. Other recent recalls of similar products include the June 8, 2026 Micro Therapeutics Pipeline Flex Embolization Device incorrect labeling risk and the March 20, 2026 Centinel Prodisc C SK U.S. Implant labeling mixup.
How to tell if you have this one
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.
Brand
Biomet
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the model number (113629) and lot number (659260) on the implant to confirm it's the recalled item.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-1543-2020 (February 17, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1543-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.