Medacta recalls specific shoulder surgery tools that may cause fractures in the upper arm during procedures due to improper positioning. Affected models include sizes 7-16 with reference numbers 04.01.10.0970-0979.
Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the stem reamer are positioned approximately 0.2 mm per size more laterally than intended, which may increase the risk of fracture in the medial region of the proximal humerus.
Medacta has recalled certain shoulder surgery tools that may cause fractures in the upper arm during procedures. These tools are designed for shoulder replacements but have a slight positioning error that could increase fracture risk in the medial region of the humerus.
The surgical instruments do not properly replicate the implant geometry, causing the reaming guide and stem reamer to be positioned about 0.2 mm further laterally than intended. This slight misalignment may increase the risk of fracture in the medial region of the proximal humerus during surgery.
Surgical patients undergoing shoulder replacement procedures who use these specific Medacta tools. Patients with the referenced model numbers are most at risk.
Check for model numbers 04.01.10.0970 through 04.01.10.0979 on the packaging or tool itself. These are part of the Medacta Shoulder System used in shoulder replacement surgeries.
Look for model numbers 04.01.10.0970 through 04.01.10.0979 on the packaging or tool itself.
The tools may position the reaming guide and stem reamer approximately 0.2 mm further laterally than intended, which could increase fracture risk in the medial region of the proximal humerus during shoulder replacement surgery.
Check for model numbers 04.01.10.0970 through 04.01.10.0979 on the packaging or tool itself. These are part of the Medacta Shoulder System used in shoulder replacement procedures.
The recall does not specify a stop-use instruction, so you can continue using them but should check if you have the recalled model numbers.
We’ve drafted a message you can send Medacta to request your refund or repair — edit it as you like.
Subject: Recall Z-2618-2026 — Medacta Medacta Hello, I own a Medacta that is covered by recall Z-2618-2026 from Medacta. 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.
